CN112526019A - Method for detecting contents of various components in ammonia Meiyusu oral solution by using HPLC (high performance liquid chromatography) method - Google Patents

Abstract

The invention discloses a method for detecting contents of various components in an ammonia Meiyusu oral solution by using an HPLC method, wherein the chromatographic conditions of the HPLC method are as follows: using octadecylsilane chemically bonded silica as filler, using the mixed solution of phosphate buffer solution and methanol as mobile phase A, and using the mixed solution of phosphate buffer solution and acetonitrile as mobile phase B to carry out gradient elution at flow rate of 0.5-1.5ml per minute, column temperature of 25-40 ℃, and detection wavelength of 200-254 nm. The method can be used for simultaneously detecting the acetaminophen, the dextromethorphan hydrobromide, the guaiacol glyceryl ether, the phenylephrine hydrochloride, the sodium benzoate and the propylpeinate in the ammeinem oral solution, and performing component identification on common peaks in the oral solution, has good reproducibility and high accuracy, and is suitable for quality control of the content of active components in the ammeinem oral solution.

Description

Method for detecting contents of various components in ammonia Meiyusu oral solution by using HPLC (high performance liquid chromatography) method

Technical Field

The invention relates to the technical field of pharmaceutical analysis, in particular to a method for detecting contents of various components in an ammonia mery oral solution by using an HPLC method.

Background

The ammeistin oral solution consists of active ingredients of acetaminophen, dextromethorphan hydrobromide, guaiacol glyceryl ether and phenylephrine hydrochloride as well as a certain amount of inactive ingredients such as auxiliary materials of cosolvent, flavoring agent, preservative, antioxidant, oxygen-assisting agent, pH regulator and the like, is a medicament for treating children multi-symptom cold and fever, has the effects of treating and relieving common cold and influenza symptoms such as nasal obstruction, cough and intensity of buffer caused by slight throat and bronchial inflammation cough, can treat and relieve slight pain, headache and sore throat, temporarily reduces fever, and is beneficial to relieving phlegm (mucus) and discharging of bronchiole secretion.

Strict quality control is necessary to ensure the safety and effectiveness of the drug. The individual acetaminophen, dextromethorphan hydrobromide, guaiacol glyceryl ether, phenylephrine hydrochloride and the like have relatively mature detection methods, for example: acetaminophen is spectrophotometred, dextromethorphan hydrobromide is chromatographed using high performance liquid chromatography, guaiacol glyceryl ether is titrated, and phenylephrine hydrochloride is titrated. However, after the preparation is prepared into a compound preparation, if the content of each component is detected by the method, the method is not feasible, and even if the method is barely feasible, the problems of manpower and material resources waste, resource waste and environmental pollution exist.

In the prior art, methods for simultaneously detecting multiple components in a compound preparation by using a high performance liquid chromatography are also available, but many of the methods have the disadvantage of inaccurate detection results, for example, the method for analyzing the ammonia Meiyu soft capsule by using the high performance liquid chromatography with the application number of CN201410379846.0 adopts a sodium octane sulfonate solution containing 0.1 v% of triethylamine as a mobile phase A and acetonitrile as a mobile phase B, and performs component separation by using a gradient elution method. After the sodium octane sulfonate ion pair reagent is added, triethylamine is added into the mobile phase, so that the mobile phases are influenced mutually, and the acetaminophen and the guaiacol glycerol ether are also influenced. Meanwhile, a chromatographic column of the high performance liquid is mostly a packed column of octadecylsilane chemically bonded silica, and triethylamine is easy to damage the column. The method for detecting six active ingredients in a drug sample with application number CN201610743206.2 comprises the following steps of: mobile phase a, which is an aqueous solution containing 0.1 v/v% trifluoroacetic acid, and mobile phase B, which is a mixed solution of acetonitrile and methanol at a volume ratio of 60:40 ". Although it is also possible to detect a plurality of components at once, it has significant disadvantages. Trifluoroacetic acid (TFA), a strong carboxylic acid, has an effect on several major active ingredients in the present invention due to the specific structure of trifluoromethyl group, and particularly on acetaminophen, which is hydrolyzed, and thus, accuracy of the detection result may be seriously affected.

Disclosure of Invention

The invention aims to provide a method for detecting contents of various components in an ammonia Meiyusu oral solution by using an HPLC (high performance liquid chromatography) method, and solves the problem of inaccurate measurement result caused by the existing method for simultaneously measuring various components in an ammonia Meiyusu compound preparation.

The invention is realized by the following technical scheme:

a method for detecting the content of various components in an oral solution of amitocin by using an HPLC method is characterized in that the chromatographic conditions of the HPLC method are as follows:

using octadecylsilane chemically bonded silica as filler, using the mixed solution of phosphate buffer solution and methanol as mobile phase A, and using the mixed solution of phosphate buffer solution and acetonitrile as mobile phase B to carry out gradient elution at flow rate of 0.5-1.5ml per minute, column temperature of 25-40 ℃, and detection wavelength of 200-254 nm.

The type of the chromatographic column, the composition of the mobile phase and the flow rate all can significantly influence the retention time, the separation degree, the tailing factors and the like related to the HPLC method, and influence the accuracy of the detection results of main components and impurities.

The applicant found through experiments that:

by adopting the chromatographic conditions, the paracetamol, dextromethorphan hydrobromide, guaiacol glyceryl ether, phenylephrine hydrochloride, sodium benzoate and propylparaben in the oral liquid of ametocin can be detected simultaneously, all main peaks in the oral liquid of ametocin are subjected to component identification, and the oral liquid of ametocin has good reproducibility and high accuracy and is suitable for quality control of the content of active components in the oral liquid of ametocin.

In addition, the phosphate buffer solution, the methanol and the acetonitrile adopted in the invention have no influence on the components in the detection column and the ammonia Meiyusu oral solution.

Further, the volume ratio of the phosphate buffer solution to the methanol in the mobile phase A is 90:10, and the volume ratio of the phosphate buffer solution to the acetonitrile in the mobile phase B is 25: 75.

Further, the conditions of gradient elution are:

0-6 min, mobile phase A90-90%, mobile phase B10-10%; 6-20 minutes, mobile phase A90-65%, mobile phase B10-35%; 20-30 minutes, 65-50% of mobile phase A and 35-50% of mobile phase B; 30-40 minutes, mobile phase A50-10%, mobile phase B50-90%; 40-55 minutes, 90-90% of mobile phase A and 10-10% of mobile phase B.

Further, the number of theoretical plates is 1000 or more.

Further, the phosphate buffer solution is a buffer solution containing 30mmol/L sodium dihydrogen phosphate and 2.50g/L sodium octane sulfonate, and the pH value is adjusted to 3.0 by phosphoric acid.

Further, the flow rate was 1.0ml per minute, the column temperature was 30 ℃ and the detection wavelength was 220 nm.

Further, the method comprises the following steps:

s1, preparation of control solutions: respectively weighing reference substances of acetaminophen, dextromethorphan hydrobromide, guaiacol glyceryl ether, phenylephrine hydrochloride, sodium benzoate and propylparaben, dissolving by using a mobile phase A, and quantitatively diluting to prepare solutions containing 325.0 mu g of acetaminophen, 10.0 mu g of dextromethorphan hydrobromide, 200.0 mu g of guaiacol glyceryl ether, 5.0 mu g of phenylephrine hydrochloride, 20.0 mu g of sodium benzoate and 20.0 mu g of propylparaben in each 1ml, wherein the solutions are respectively used as reference substance solutions;

s2, preparation of a test solution: measuring ammonia Mei Yu Su oral solution, quantitatively diluting with mobile phase A to obtain ammonia Mei Yu Su oral solution containing 0.01ml of ammonia Mei Yu Su per 1ml, filtering, and taking filtrate as test solution;

s3, detection: precisely absorbing 5 μ l and 20 μ l of the reference solution and 5 μ l and 20 μ l of the test solution, injecting into a liquid chromatograph to obtain chromatogram, and calculating the content of each component according to peak area in the chromatogram.

The specific formulation of the oral solution is as follows:

active ingredients: 28.0-35.0g of acetaminophen, 15.0-25.0g of guaiacol glyceryl ether, 0.4-0.6g of phenylephrine hydrochloride and 0.8-1.2g of dextromethorphan hydrobromide;

other auxiliary components: 1.5-2.5g stabilizer, 400.0-600.0g cosolvent, 95.0-110.0g flavoring agent 0.8-1.0g, thickening agent 2.5-3.2g, pH regulator 0.4-0.6g, complexing agent 1.9-2.1g, pigment 30.0-35.0mg, aromatic 3.0-5.0ml and preservative;

the solvent was added to a total volume of 1000 ml.

The stabilizer is propyl gallate, the cosolvent is a mixture of glycerol and propylene glycol, the flavoring agent is a mixture of sorbitol and sucralose, the thickening agent is xanthan gum, the pH regulator is a mixture of anhydrous citric acid and sodium citrate, the preservative is sodium benzoate, the complexing agent is disodium edetate, the flavoring agent is a mixture of grape essence and blueberry essence, the pigment is a mixture of allura red pigment and brilliant blue pigment, and the solvent is purified water.

Compared with the prior art, the invention has the following advantages and beneficial effects:

1. the method can detect a plurality of components at one time, can realize the simultaneous determination of acetaminophen, phenylephrine hydrochloride, guaiacol glyceryl ether, dextromethorphan hydrobromide, sodium benzoate and propyl gallate, has the advantages of simple operation, quick analysis, good repeatability and good specificity, improves the efficiency and saves the cost.

2. The triethylamine is avoided, the influence of the triethylamine on the flowing sodium alkyl sulfonate is avoided, and the influence on the acetaminophen and the guaiacol glyceryl ether is also avoided. Meanwhile, the damage to the chromatographic column is prevented; the method avoids using trifluoroacetic acid, solves the problem of influence of trifluoroacetic acid on a plurality of main active ingredients in the preparation, and greatly improves the accuracy of detection results.

3. The invention uses the mobile phase A as the solvent to prepare the reference solution, and solves the problem that the accuracy of the detection result is influenced because the guaiacol glyceryl ether and the propyl gallate are not dissolved in water.

4. According to the invention, the sodium octane sulfonate ion pair reagent is added into the mobile phase system, so that the retention of phenylephrine hydrochloride is increased, the peak shape is improved, and the separation degree is increased; the mobile phase is greatly changed from 40 minutes to 40.1 minutes of gradient elution, the dextromethorphan hydrobromide tailing is effectively improved, and the dextromethorphan hydrobromide tailing has good tolerance to different chromatographic columns.

5. The detection method of the invention can completely separate each component, has good peak shape, ensures that the response value of each component measured by a sample is in a proper range, and has no harm to a solvent.

Drawings

Fig. 1 is a chromatogram of a control solution, wherein 1: acetaminophen; 2: guaifenesin; 3: phenylephrine hydrochloride; 4: sodium benzoate; 5: propyl gallate; 6: dextromethorphan hydrobromide.

Fig. 2 is a chromatogram of a test solution, in which 1: acetaminophen; 2: guaifenesin; 3: phenylephrine hydrochloride; 4: sodium benzoate; 5: propyl gallate; 6: dextromethorphan hydrobromide.

Detailed Description

In order to make the objects, technical solutions and advantages of the present invention more apparent, the present invention is further described in detail below with reference to examples and accompanying drawings, and the exemplary embodiments and descriptions thereof are only used for explaining the present invention and are not meant to limit the present invention.

Example (b):

1. chromatographic conditions and system applicability test: chromatographic column with octadecylsilane chemically bonded silica as filler (ACE Excel C18, 4.6mm × 250mm, 5 μm); gradient elution was performed according to Table 1 using phosphate buffer (30 mmol/L sodium dihydrogen phosphate, 2.50g/L sodium octane sulfonate, pH adjusted to 3.0 with phosphoric acid) -methanol (90:10) as mobile phase A and the above phosphate buffer-acetonitrile (25:75) as mobile phase B at a flow rate of 1.0ml per minute and a column temperature of 30 ℃ and a detection wavelength of 220 nm.

TABLE 1 gradient elution

2. Preparation of control solutions: taking a proper amount of acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride, sodium benzoate and propylpeinate, precisely weighing, dissolving by using a mobile phase A, and quantitatively diluting to prepare a solution containing about 325.0 mu g of acetaminophen, 10.0 mu g of dextromethorphan hydrobromide, 200.0 mu g of guaifenesin, 5.0 mu g of phenylephrine hydrochloride, 20.0 mu g of sodium benzoate and 20.0 mu g of propylpeinate in each 1ml, wherein the solution is used as a reference solution;

3. preparation of a test solution: precisely measuring an appropriate amount of AMMEIYUSU oral solution, quantitatively diluting with the mobile phase A to obtain AMMEIYUSU oral solution containing about 0.01ml of AMMEIYUSU per 1ml, filtering, and collecting the filtrate as test solution;

4. and (3) detection: precisely sucking 5 μ l and 20 μ l of reference solution and 5 μ l and 20 μ l of test solution, respectively, injecting into liquid chromatograph to obtain reference chromatogram (figure 1) and test chromatogram (figure 2), and calculating peak areas according to external standard method to obtain the content of acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride, sodium benzoate and propyl gallate in the oral liquid.

The specific formulation of the oral solution is as follows:

active ingredients: 28.0-35.0g of acetaminophen, 15.0-25.0g of guaiacol glyceryl ether, 0.4-0.6g of phenylephrine hydrochloride and 0.8-1.2g of dextromethorphan hydrobromide;

other auxiliary components: 1.5-2.5g stabilizer, 400.0-600.0g cosolvent, 95.0-110.0g flavoring agent 0.8-1.0g, thickening agent 2.5-3.2g, pH regulator 0.4-0.6g, complexing agent 1.9-2.1g, pigment 30.0-35.0mg, aromatic 3.0-5.0ml and preservative;

the solvent was added to a total volume of 1000 ml.

The stabilizer is propyl gallate, the cosolvent is a mixture of glycerol and propylene glycol, the flavoring agent is a mixture of sorbitol and sucralose, the thickening agent is xanthan gum, the pH regulator is a mixture of anhydrous citric acid and sodium citrate, the preservative is sodium benzoate, the complexing agent is disodium edetate, the flavoring agent is a mixture of grape essence and blueberry essence, the pigment is a mixture of allura red pigment and brilliant blue pigment, and the solvent is purified water.

As can be seen from fig. 1 and 2:

the method can be used for simultaneously detecting the acetaminophen, the dextromethorphan hydrobromide, the guaiacol glyceryl ether, the phenylephrine hydrochloride, the sodium benzoate and the propylpeinate in the ammeisu oral solution, and has the advantage of high accuracy because the main peaks are subjected to component identification.

The above implementation was verified using a partial methodology study experiment:

1. study of system applicability test:

1.1 study sample preparation:

precisely measuring a proper amount of a reference substance, and adjusting the pH value to 3.0 by using a phosphate buffer solution (30 mmol/L sodium dihydrogen phosphate, 2.50g/L sodium octane sulfonate) through phosphoric acid: taking methanol as a mobile phase A, taking the methanol as 90:10, quantitatively diluting the mobile phase A to prepare a solution containing approximately 325.0 mu g, 10.0 mu g, 200.0 mu g, 5.0 mu g, 20.0 mu g and 20.0 mu g of propyl gallate in each 1ml of acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride, sodium benzoate and propyl gallate, respectively, filtering, injecting 20 mu l of the solution into a liquid chromatograph, continuously injecting the sample for 5 times, then injecting 5 mu l of the solution into the liquid chromatograph, and continuously injecting the sample for 5 times.

1.2 study results: the minimum separation of adjacent peaks, number of theoretical plates, symmetry factor, retention time and% RSD of peak area are shown in table 2:

TABLE 2

Name (R)	Retention time	Number of theoretical plates	Degree of separation	Symmetry factor	RSD％
						Acetaminophen	7.151	14500	6.761	1.149	0.03
Guaiacol glyceryl ether	2.293	121816	11.232	1.113	0.02
						Phenylephrine hydrochloride	25.566	290159	14.569	1.131	0.08
Dextromethorphan hydrobromide	39.396	898309	54.234	1.166	0.11
						Sodium benzoate	26.942	147344	5.845	1.086	0.02
Propyl gallate	27.878	186350	3.473	1.119	0.02

And (4) conclusion: RSD is less than 2, and rechecking is required.

2. Accuracy study:

the test method comprises the following steps: according to three concentration design tests of 120%, 100% and 80%, paracetamol, dextromethorphan hydrobromide, guaiacol glyceryl ether, phenylephrine hydrochloride, sodium benzoate and propyl gallate are precisely weighed respectively, as shown in table 3, a solution is prepared according to a prescription, concentration samples are prepared in three parts in parallel according to the HPLC method, and the recovery rate is calculated according to the previous method test and is shown in table 4:

TABLE 3

TABLE 4

Name (R)	Recovery rate	RSD％
			Acetaminophen	100％	1.17
Guaiacol glyceryl ether	101％	1.05
			Phenylephrine hydrochloride	101％	1.01
Dextromethorphan hydrobromide	98％	1.09
			Sodium benzoate	99％	0.24
Propyl gallate	99％	0.87

The recovery rate is 98-102%, the RSD is less than or equal to 2%, and the rechecking requirement is met.

3. Study of linearity

3.1. Sample preparation: taking acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride, sodium benzoate and propyl gallate reference substances, respectively placing the reference substances into 10ml volumetric flasks as shown in Table 5, adding the mobile phase A to dissolve and dilute the reference substances to a scale, and shaking the reference substances uniformly to prepare the series of solutions. And respectively injecting 20 mu l of the mixture into a liquid chromatograph, recording the chromatogram, then respectively injecting 5 mu l of the mixture into the liquid chromatograph, recording the chromatogram, and making a standard curve chart by using the peak area to the concentration.

TABLE 5

The results of the study are shown in table 6:

TABLE 6

R²Not less than 0.999, and meets the requirement.

4. Precision-repeatability/reproducibility study

4.1 taking a proper amount of acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride, sodium benzoate and propyl gallate reference substances, precisely weighing, dissolving by using a mobile phase A, quantitatively diluting to prepare solutions respectively containing 325.0 mu g, 10.0 mu g, 200.0 mu g, 5.0 mu g, 20.0 mu g and 20.0 mu g in each 1ml, and filtering; taking the ammonia Meiyusu oral solution, preparing 6 test samples in parallel, calculating the sample content (%), and inspecting the precision of the content determination method.

4.2 study results: the content of the component to be measured in the sample and the acceptable range of the precision are referred to tables 7 and 8, and tables 7 and 8 are respectively the content of the component to be measured in the sample and the acceptable range of the precision RSD.

TABLE 7

The content of the component to be measured	Repeatability (RSD%)	Reproducibility of
			100％	1	2
10％	1.5	3
			1％	2	4
0.1％	3	6
			0.01％	4	8
10μg/g(ppm)	6	11
			1μg/g	8	16
10μg/kg(ppb	15	32

TABLE 8

Name (R)	RSD％
		Acetaminophen	0.75
Guaiacol glyceryl ether	0.68
		Phenylephrine hydrochloride	0.85
Dextromethorphan hydrobromide	0.80
		Sodium benzoate	0.67
Propyl gallate	0.88

As a result: the content of acetaminophen and guaiacol glyceryl ether is between 10 and 1 percent; the content of phenylephrine hydrochloride and dextromethorphan hydrobromide is between 0.1 and 0.01 percent; the content of sodium benzoate and propyl gallate is between 1 percent and 0.1 percent, and the double-nuclear requirement is met.

5. Stability test of solution

Taking acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride, sodium benzoate and propyl gallate reference substances, preparing a reference substance solution according to a content measurement method, measuring the content after 0, 12, 24, 48, 72, 96 and 120 hours, and inspecting the stability of the solution, wherein the results are shown in Table 9:

TABLE 9

And (4) conclusion: RSD recheck requirement

6. Study of specificity test:

6.1 test design and sample preparation method

High temperature, strong light, strong acid, strong base and oxidation are used to accelerate the degradation of the product, so as to investigate the specificity of the chromatographic condition.

Taking ammonia Meiyusu oral solution, respectively carrying out high temperature, strong light, strong acid, strong base and oxidative damage tests according to the method shown in the table 10, then respectively injecting 20 mu l of a-h sample solution under each degradation condition into a liquid chromatograph, recording chromatograms, respectively injecting 5 mu l of the sample solution into the liquid chromatograph, recording the chromatograms, and preparing the sample for the special test of the related substance inspection method as shown in the table 10:

watch 10

6.2 conclusion: the maximum absorption wavelength and peak purity of the main component detected by the PDA detector meet the requirements. The main components are completely separated and do not interfere with each other.

7. Durability test study:

taking acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride, sodium benzoate and propyl gallate reference substances, preparing according to a content measurement method, measuring according to the content measurement method under the following conditions, and calculating the content. Sample of the test article: and (3) preparation mixing destruction: taking 2ml of each special damage sample, mixing uniformly, wherein 0.00001625mg of p-chlorophenylacetamide, 0.00001625mg of p-aminophenol, A0.0004mg of guaiacol glyceryl ether impurity, B0.0004mg of guaiacol glyceryl ether impurity, C0.0004mg of guaiacol glyceryl ether impurity, D0.0004mg of guaiacol glyceryl ether impurity, A0.000025mg of phenylephrine hydrochloride impurity, C0.000025mg of phenylephrine hydrochloride impurity, D0.000025mg of phenylephrine hydrochloride impurity, 0.000025mg of dextromethorphan hydrobromide impurity, B0.00004mg of dextromethorphan hydrobromide impurity, C0.00004mg of dextromethorphan hydrobromide impurity, 0.45 mu m of filtration, and discarding 1ml of primary filtrate are added to the special damage sample under the concentration to obtain the product. And (3) mixing and destroying blank auxiliary materials, uniformly mixing 2ml of special destroyed samples, filtering by 0.45 mu m, and discarding 1ml of primary filtrate to obtain the special destroyed sample, wherein the test conditions and results are shown in Table 11:

TABLE 11

And (4) conclusion: 0.06% of acetaminophen, 0.11% of guaiacol glyceryl ether, 0.34% of phenylephrine hydrochloride, 0.13% of dextromethorphan hydrobromide, 0.32% of sodium benzoate, 1.03% of propyl gallate, and the RSD value of less than 2%, and meets the design requirement of rechecking.

In conclusion, the method can be used for simultaneously detecting the acetaminophen, the dextromethorphan hydrobromide, the guaiacol glyceryl ether, the phenylephrine hydrochloride, the sodium benzoate and the propylpehenate in the ammeinto oral solution, and identifying the components of main peaks of the oral solution, has the advantages of good reproducibility and high accuracy, and is suitable for quality control of the content of active components in the ammeinto oral solution.

The above-mentioned embodiments are intended to illustrate the objects, technical solutions and advantages of the present invention in further detail, and it should be understood that the above-mentioned embodiments are merely exemplary embodiments of the present invention, and are not intended to limit the scope of the present invention, and any modifications, equivalent substitutions, improvements and the like made within the spirit and principle of the present invention should be included in the scope of the present invention.

Claims (7)

1. A method for detecting contents of various components in an oral solution of ametocin by using an HPLC method is characterized in that the chromatographic conditions of the HPLC method are as follows:

using octadecylsilane chemically bonded silica as filler, using the mixed solution of phosphate buffer solution and methanol as mobile phase A, and using the mixed solution of phosphate buffer solution and acetonitrile as mobile phase B to carry out gradient elution at flow rate of 0.5-1.5ml per minute, column temperature of 25-40 ℃, and detection wavelength of 200-254 nm.

2. The method for detecting the contents of multiple components in the ametocin oral solution by the HPLC method as claimed in claim 1, wherein the volume ratio of the phosphate buffer solution to methanol in the mobile phase A is 90:10, and the volume ratio of the phosphate buffer solution to acetonitrile in the mobile phase B is 25: 75.

3. The method for detecting the contents of a plurality of components in the ametocin oral solution by the HPLC method according to claim 1, wherein the conditions of the gradient elution are as follows:

0-6 min, mobile phase A90-90%, mobile phase B10-10%; 6-20 minutes, mobile phase A90-65%, mobile phase B10-35%; 20-30 minutes, 65-50% of mobile phase A and 35-50% of mobile phase B; 30-40 minutes, mobile phase A50-10%, mobile phase B50-90%; 40-55 minutes, 90-90% of mobile phase A and 10-10% of mobile phase B.

4. The method for detecting the contents of various components in the ammenilin oral solution by the HPLC method as claimed in claim 1, wherein the number of theoretical plates is greater than or equal to 1000.

5. The method for detecting contents of various components in the ammexican oral solution according to claim 1, wherein the phosphate buffer solution is a buffer solution containing 30mmol/L sodium dihydrogen phosphate and 2.50g/L sodium octane sulfonate, and the pH is adjusted to 3.0 with phosphoric acid.

6. The method for detecting the contents of multiple components in the ametocin oral solution by the HPLC method as claimed in claim 1, wherein the flow rate is 1.0ml per minute, the column temperature is 30 ℃, and the detection wavelength is 220 nm.

7. The method for detecting the contents of a plurality of components in the ammenicin oral solution by the HPLC method according to any one of claims 1 to 6, which comprises the following steps:

s1, preparation of control solutions: respectively weighing reference substances of acetaminophen, dextromethorphan hydrobromide, guaiacol glyceryl ether, phenylephrine hydrochloride, sodium benzoate and propylparaben, dissolving by using a mobile phase A, and quantitatively diluting to prepare solutions containing 325.0 mu g of acetaminophen, 10.0 mu g of dextromethorphan hydrobromide, 200.0 mu g of guaiacol glyceryl ether, 5.0 mu g of phenylephrine hydrochloride, 20.0 mu g of sodium benzoate and 20.0 mu g of propylparaben in each 1ml, wherein the solutions are respectively used as reference substance solutions;

s2, preparation of a test solution: measuring ammonia Mei Yu Su oral solution, quantitatively diluting with mobile phase A to obtain ammonia Mei Yu Su oral solution containing 0.01ml of ammonia Mei Yu Su per 1ml, filtering, and taking filtrate as test solution;

s3, detection: precisely sucking 5 μ l and 20 μ l of the reference solution and 5 μ l and 20 μ l of the test solution, and injecting into a liquid chromatograph to obtain chromatogram.

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