CN112083089A - Method for detecting dissolution curve of telmisartan tablets - Google Patents
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- G01N30/00—Investigating or analysing materials by separation into components using adsorption, absorption or similar phenomena or using ion-exchange, e.g. chromatography or field flow fractionation
- G01N30/02—Column chromatography
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- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N30/00—Investigating or analysing materials by separation into components using adsorption, absorption or similar phenomena or using ion-exchange, e.g. chromatography or field flow fractionation
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- G01N30/02—Column chromatography
- G01N30/26—Conditioning of the fluid carrier; Flow patterns
- G01N30/28—Control of physical parameters of the fluid carrier
- G01N30/30—Control of physical parameters of the fluid carrier of temperature
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
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- G01N30/02—Column chromatography
- G01N30/26—Conditioning of the fluid carrier; Flow patterns
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- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
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- G01N30/02—Column chromatography
- G01N30/26—Conditioning of the fluid carrier; Flow patterns
- G01N30/28—Control of physical parameters of the fluid carrier
- G01N30/34—Control of physical parameters of the fluid carrier of fluid composition, e.g. gradient
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- G01N30/02—Column chromatography
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- G01N30/02—Column chromatography
- G01N30/26—Conditioning of the fluid carrier; Flow patterns
- G01N30/28—Control of physical parameters of the fluid carrier
- G01N30/32—Control of physical parameters of the fluid carrier of pressure or speed
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Abstract
The invention relates to a method for detecting a dissolution curve of telmisartan tablets, which comprises the following specific steps: preparing a dissolving-out medium; preparing a test solution according to the prepared dissolution medium; preparing a reference substance solution according to the prepared dissolution medium; detecting by high performance liquid chromatography. The high performance liquid chromatography method for detecting the dissolution curve of the telmisartan tablets has good specificity and high accuracy.
Description
Technical Field
The invention relates to the field of pharmacy, in particular to a method for detecting a dissolution curve of telmisartan tablets.
Background
The telmisartan tablet is used for treating primary hypertension of adults, the BCS of the telmisartan tablet is classified into II (low-solubility and high-permeability) medicines, and dissolution is the rate-limiting step of medicine absorption; the dissolution rate and dissolution amount of the main drug in the existing tablet are low, namely the dissolution rate and dissolution amount of the main drug in the tablet need to be further improved.
The preparation method for detecting the telmisartan tablets comprises the following steps: telmisartan is adopted as a raw material, and is prepared into a solution with sodium hydroxide and meglumine, after reduced pressure distillation and recrystallization, amorphous sodium salt granules with a crystal form are obtained, the granules, a filling agent and an adhesive are added into a wet mixing granulator for mixing, purified water is added for preparing a soft material, and tabletting is carried out after granulation, drying and total mixing, so that the compressibility is good and the process is stable.
In order to more accurately measure the dissolution curve of the telmisartan tablets prepared by the method, a better detection method than the original UV detection method needs to be established.
The defects and shortcomings of the prior art are as follows:
the original tablet preparation process has more procedures, large energy and manpower consumption, and large difference between a plurality of dissolution curves and a reference preparation; the original detection method is a UV method, and the detection accuracy is low.
Disclosure of Invention
In order to solve the problems, the invention provides a method for detecting a dissolution curve of telmisartan tablets, which adopts high performance liquid chromatography for detection. Compared with the traditional UV detection method, the method has the following advantages:
(1) the traditional UV detection method is based on the detection of ultraviolet absorption characteristic peak of the compound; in the invention, UV is a detector in HPLC, and in the UV detection in HPLC, a sample is separated from a sample injection substance through a chromatographic column, and then a compound is detected by using the UV detector, so that the determination result is more accurate.
(2) The traditional UV detection method needs more amount during detection, so that the detection concentration is lower, the sample needs to be diluted in the detection process, the trace sample introduction of HPLC makes the detection concentration higher, and the system error caused by multiple dilution of the sample is reduced.
(3) The HPLC detection instrument can automatically sample, is more convenient to operate, and saves the labor cost.
The detection method specifically comprises the following steps:
(1) preparing a dissolving-out medium;
(2) preparing a test solution according to the prepared dissolution medium;
(3) preparing a reference substance solution according to the prepared dissolution medium;
(4) detecting by high performance liquid chromatography.
Preferably, the dissolution medium is a hydrochloric acid solution of pH1.2, a phosphate buffer solution of pH4.5, a phosphate buffer solution of pH6.8, a phosphate buffer solution of pH7.5, a potassium dihydrogen phosphate solution of 0.2mol/L, and a sodium hydroxide solution of 0.2 mol/L.
In any of the above embodiments, the test solution is preferably a hydrochloric acid solution of ph1.2, a phosphate buffer solution of ph6.8, a phosphate buffer solution of ph7.5, or a phosphate buffer solution of ph 4.5.
In any of the above schemes, preferably, according to the determination method of dissolution rate and release rate, using pH1.2 hydrochloric acid solution, pH6.8 phosphate buffer solution, pH7.5 phosphate buffer solution 900ml as dissolution medium, rotating at 75 rpm, operating according to the method, and when different time passes, wherein pH1.2 hydrochloric acid solution medium sampling time is 5min, 10min, 15min, 20min, 30min, 45min, 60min, 90min, 120min, pH6.8 phosphate buffer solution and pH7.5 phosphate buffer solution medium sampling time is 5min, 10min, 15min, 20min, 30min, 45min, 60min, 10ml of dissolution liquid is taken, no solution is made, filtering is performed by using mixed cellulose MCE13mm 0.45 μm water filter head, at least 3ml of primary filtrate is discarded, and the secondary filtrate is taken as sample solution.
Preferably, according to the above scheme, according to the determination method of dissolution rate and release rate, 900ml of phosphate buffer solution with pH4.5 is used as dissolution medium, the rotation speed is 75 revolutions per minute, according to the method, an automatic sampling dissolution instrument is adopted, dissolution liquid is taken after 5min, 10min, 15min, 20min, 30min, 45min and 60min respectively, 1.5ml of dissolution liquid is taken, and no liquid is supplemented to serve as the test solution.
Preferably, the method for determining dissolution rate and release rate is the second method of 0931.
Preferably, the telmisartan reference substance is taken to be about 11mg, precisely weighed, placed in a 50ml measuring flask, added with a proper amount of methanol and 0.2ml of 0.1mol/L sodium hydroxide solution, ultrasonically treated to dissolve, diluted to a scale by adding methanol, shaken up and used as a reference substance stock solution; precisely measuring 5ml of the reference stock solution, placing in a 50ml measuring flask, diluting to scale with dissolution medium, and shaking to obtain reference solution.
In any of the above embodiments, preferably, 20. mu.l of each sample solution is precisely measured, injected into a liquid chromatograph, a chromatogram is recorded, and the cumulative elution amount of each tablet is calculated by an external standard method.
Preferably, in any scheme, a part of reference substance solution is taken, 20 μ l of the reference substance solution is injected into a liquid chromatograph, a chromatogram is recorded, 5 times of continuous sample introduction are carried out, and the relative standard deviation of the peak area of telmisartan which is a reference substance for 5 times of continuous sample introduction is calculated to be not more than 2.0%;
in any of the above schemes, preferably, another 20 μ l of the control solution is injected into the chromatograph, the chromatogram is recorded, and the sample is continuously injected for 2 times, wherein the goodness of fit of response factors of the two control solutions is 98.0-102.0%.
Preferably, in any of the above embodiments, the chromatographic conditions are: the chromatographic column is Kromasil KR 4.6 × 100mm 5 μm; the detector is a UV detector; the detection wavelength is 296 nm; the column temperature is 30 ℃; the flow rate is 1.0 ml/min; the sample amount is 20 mul; the collection time is 6 min; the mobile phase was 0.1% sodium dihydrogen phosphate-methanol 25: 75.
Any of the above solutions preferably the detector is a UV SPD-20A detector.
In any of the above schemes, the mobile phase preferably contains 0.2% triethylamine, and the pH value is adjusted to 5.2 by using phosphoric acid.
The invention has the beneficial effects that: the high performance liquid chromatography method for detecting the dissolution curve of the telmisartan tablets has good specificity and high accuracy.
Drawings
Fig. 1 is a diffraction pattern of a crystalline amorphous telmisartan sodium powder of telmisartan tablets prepared according to a preferred embodiment of the present invention.
FIG. 2 is an HPLC chromatogram of a control of the embodiment of FIG. 1 according to the present invention;
FIG. 3 is an HPLC chromatogram of the test sample of the embodiment shown in FIG. 1 according to the present invention.
Detailed Description
The invention is further illustrated by the following examples and figures.
The preparation method of the telmisartan tablet comprises the following steps: telmisartan is adopted as a raw material, and is prepared into a solution with sodium hydroxide and meglumine, after reduced pressure distillation and recrystallization, amorphous sodium salt granules with a crystal form are obtained, the granules, a filling agent and an adhesive are added into a wet mixing granulator for mixing, purified water is added for preparing a soft material, and the soft material is granulated, dried, totally mixed and tabletted, so that the compressibility is good.
The telmisartan tablets prepared by the method have the similarity with a plurality of dissolution curves of a reference preparation, and the product is very stable; the dissolution curve specificity and accuracy of the product are detected by adopting a newly-built and verified high performance liquid chromatography.
Preparation of a dissolution medium:
ph1.2 hydrochloric acid solution: weighing 7.65mL of hydrochloric acid, adding water to dilute the hydrochloric acid to 1000mL, and shaking up to obtain the compound.
pH4.5, pH6.8, pH7.5 phosphate buffer:
0.2mol/L potassium dihydrogen phosphate solution: 27.22g of potassium dihydrogen phosphate were taken, dissolved in water and diluted to 1000 mL.
0.2mol/L sodium hydroxide solution: 8.00g of sodium hydroxide was taken, dissolved in water and diluted to 1000 mL.
250mL of 0.2mol/L potassium dihydrogen phosphate solution is mixed with 0.2mol/L sodium hydroxide solution specified in the table, and then water is added to dilute the mixture to 1000mL, and the mixture is shaken up to obtain the potassium dihydrogen phosphate.
TABLE 1 phosphate buffer
| pH value | 4.5 | 6.8 | 7.5 |
| 0.2mol/L sodium hydroxide solution (mL) | 0 | 112 | 200 |
Preparing a test solution:
preparing test solution of pH1.2 hydrochloric acid solution, pH6.8 phosphate buffer solution and pH7.5 phosphate buffer solution: taking the product, according to dissolution and release determination method (second method of 0931), respectively taking pH1.2 hydrochloric acid solution, pH6.8 phosphate buffer solution, and pH7.5 phosphate buffer solution 900ml as dissolution medium, rotating at 75 rpm, operating according to the method, taking 10ml dissolution solution and no supplementary solution after different time (sampling time of pH1.2 medium is 5min, 10min, 15min, 20min, 30min, 45min, 60min, 90min, 120min, and sampling time of pH6.8 and pH7.5 medium is 5min, 10min, 15min, 20min, 30min, 45min, 60min), filtering with mixed cellulose MCE water filter head (13mm × 0.45 μm), discarding at least 3ml primary filtrate, and taking the subsequent filtrate as sample solution.
preparation of a test solution of phosphate buffer solution with pH 4.5: taking the product, determining dissolution rate and release rate (second method of 0931), taking 900ml of pH4.5 phosphate buffer solution as dissolution medium at 75 rpm, taking dissolution solution for 5min, 10min, 15min, 20min, 30min, 45min, and 60min respectively by automatic sampling dissolution instrument, and taking 1.5ml of dissolution solution as sample solution.
Three control solutions
Taking telmisartan reference substance about 11mg, precisely weighing, placing in a 50ml measuring flask, adding a proper amount of methanol, adding 0.2ml of 0.1mol/L sodium hydroxide solution, performing ultrasonic treatment to dissolve, adding methanol to dilute to a scale, shaking up, and taking the solution as reference substance stock solution; precisely measuring 5ml of the reference stock solution, placing in a 50ml measuring flask, diluting to scale with dissolution medium, and shaking to obtain reference solution.
Four assay
The chromatographic conditions were as follows:
the instrument comprises the following steps: high performance liquid chromatograph
A chromatographic column: kromasil KR 4.6X 100mm 5 μm or column with similar column efficiency
A detector: UV detector
Detection wavelength: 296nm
Column temperature: 30 deg.C
Flow rate: 1.0ml/min
Collecting time: 6min
Sample introduction amount: 20 μ l
Mobile phase: 0.1% monosodium phosphate-methanol 25: 75 (containing 0.2% triethylamine, pH 5.2 adjusted with phosphoric acid)
And (3) carrying out detection according to the chromatographic condition, injecting a part of reference substance solution into a liquid chromatograph, recording the chromatogram, carrying out continuous sample injection for 5 times, and calculating the relative standard deviation of the peak area of telmisartan which is the reference substance for 5 continuous times to be not more than 2.0%. And injecting the other part of the reference substance solution into a chromatograph, recording a chromatogram, and continuously injecting the sample for 2 times, wherein the goodness of fit of response factors of the two parts of the reference substance solution is 98.0-102.0%.
And (3) injecting the test solution into a liquid chromatograph, recording the chromatogram, and calculating the accumulated dissolution amount of each tablet according to an external standard method.
Five calculation formulas and test results
(1) Formula for calculation
In the formula:
ar is the peak area of the reference;
dr is the dilution factor of the reference substance;
wr is the weight of the reference substance, mg;
p is the content of the telmisartan reference substance;
s is the specification of a sample, mg;
v is the sampling volume of the dissolution liquid, ml;
rt is the reference cumulative dissolution amount;
tt is the cumulative elution amount of the sample;
n is the number of sampling points.
(2) Test results
The results of 0 day and 6 month accelerated dissolution tests on 6 batches of the test articles are shown in table 2.
TABLE 2 dissolution test results
The results of the similarity factors between the test and reference reagents are shown in Table 3:
TABLE 3 test and reference preparations f2(similarity factor)
Remarking: the 15-minute accumulated dissolution amount of the common tablets is more than 80 percent, namely the tablets are similar to a reference; ② the similarity factor is larger than 50, the similarity is considered as the reference preparation.
Fig. 1 is a diffraction pattern of a crystalline amorphous telmisartan sodium powder of the prepared telmisartan tablets. As shown in figure 1, telmisartan is used as a raw material, and is prepared into a solution with sodium hydroxide and meglumine, and the solution is subjected to reduced pressure distillation and recrystallization to obtain a crystal form amorphous sodium salt particle.
FIG. 2 is an HPLC chromatogram of a control of the embodiment shown in FIG. 1; FIG. 3 is an HPLC chromatogram of the test sample of the example shown in FIG. 1. The results of fig. 2 and 3 show that the telmisartan tablet is measured by high performance liquid chromatography with high accuracy.
In addition, it should be noted that the detection method of the present invention is also applicable to telmisartan tablets prepared by other methods.
It will be understood by those skilled in the art that a method of detecting a dissolution profile of telmisartan tablets of the present invention includes any combination of the summary and the detailed description of the invention in the above description, is limited to space and is not described in any way as to the scheme formed by these combinations for the sake of brevity. Any modification, equivalent replacement, or improvement made within the spirit and principle of the present invention should be included in the protection scope of the present invention.
Claims (10)
1. A method for detecting a dissolution curve of telmisartan tablets comprises the following specific steps:
(1) preparing a dissolving-out medium;
(2) preparing a test solution according to the prepared dissolution medium;
(3) preparing a reference substance solution according to the prepared dissolution medium;
(4) detecting by high performance liquid chromatography.
2. The method for detecting the dissolution profile of telmisartan tablets according to claim 1, wherein the dissolution media are a hydrochloric acid solution at ph1.2, a phosphate buffer solution at ph4.5, a phosphate buffer solution at ph6.8, a phosphate buffer solution at ph7.5, a potassium dihydrogen phosphate solution at 0.2mol/L, and a sodium hydroxide solution at 0.2 mol/L.
3. The method for detecting the dissolution curve of telmisartan tablets according to claim 2, wherein the hydrochloric acid solution with pH1.2, the phosphate buffer solution with pH6.8 and the phosphate buffer solution with pH7.5 are used as dissolution media, the rotation speed is 75 rpm, according to the dissolution and release degree determination method, the hydrochloric acid solution with pH1.2 is sampled for 5min, 10min, 15min, 20min, 30min, 45min, 60min, 90min and 120min, the phosphate buffer solution with pH6.8 and the phosphate buffer solution with pH7.5 are sampled for 5min, 10min, 15min, 20min, 30min, 45min and 60min, 10ml of dissolution solution is taken, no solution is supplemented, the mixed cellulose MCE13mm 0.45 μm water filter head is used for filtering, at least 3ml of primary filtrate is discarded, and the secondary filtrate is taken as the sample solution.
4. The method for detecting the dissolution curve of the telmisartan tablets as claimed in claim 2, wherein 900ml of the phosphate buffer solution with the pH value of 4.5 is used as a dissolution medium, the rotation speed is 75 revolutions per minute, according to the method, an automatic sampling dissolution instrument is adopted to take dissolution liquid after 5min, 10min, 15min, 20min, 30min, 45min and 60min respectively, and 1.5ml of the dissolution liquid is taken without supplementing liquid to be used as a test solution.
5. The method for determining the dissolution profile of telmisartan tablets according to claim 3 or 4, wherein the dissolution and release assay is the second method of general rule 0931.
6. The method for detecting the dissolution curve of the telmisartan tablet according to claim 1, wherein the preparation process of the reference solution is as follows: taking telmisartan reference substance about 11mg, precisely weighing, placing in a 50ml measuring flask, adding a proper amount of methanol, adding 0.2ml of 0.1mol/L sodium hydroxide solution, performing ultrasonic treatment to dissolve, adding methanol to dilute to a scale, shaking up, and taking the solution as reference substance stock solution; precisely measuring 5ml of the reference stock solution, placing in a 50ml measuring flask, diluting to scale with dissolution medium, and shaking to obtain reference solution.
7. The method for detecting the dissolution curve of the telmisartan tablets as claimed in claim 1, wherein the liquid chromatography detection process comprises precisely measuring 20 μ l of each of the test sample solutions, injecting the measured sample solutions into a liquid chromatograph, recording a chromatogram, and calculating the cumulative dissolution amount of each tablet according to an external standard method.
8. The method for detecting the dissolution curve of the telmisartan tablet as claimed in claim 1, wherein the liquid chromatography detection process comprises the steps of taking 20 μ l of a reference substance solution, injecting the solution into a liquid chromatograph, recording a chromatogram, continuously injecting samples for 5 times, and calculating the relative standard deviation of the peak area of the telmisartan tablet of the reference substance for 5 consecutive times, wherein the relative standard deviation is not more than 2.0%.
9. The method for detecting the dissolution curve of the telmisartan tablets as claimed in claim 1, wherein the liquid chromatography detection process comprises the steps of taking another 20 μ l of control solution, injecting the solution into a chromatograph, recording a chromatogram, and continuously injecting samples for 2 times, wherein the goodness of fit of response factors of the two control solutions is 98.0-102.0%.
10. The method for detecting the dissolution curve of telmisartan tablets according to claim 1, wherein the chromatographic conditions of the liquid chromatography detection are as follows: the chromatographic column is Kromasil KR 4.6 × 100mm 5 μm; the detector is a UV detector SPD-20A; the detection wavelength is 296 nm; the column temperature is 30 ℃; the flow rate is 1.0 ml/min; the sample amount is 20 mul; the collection time is 6 min; the mobile phase was 0.1% sodium dihydrogen phosphate-methanol 25: 75, containing 0.2% triethylamine, and was adjusted to pH 5.2 with phosphoric acid.
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Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN107137370A (en) * | 2017-04-01 | 2017-09-08 | 重庆康刻尔制药有限公司 | A kind of telmisartan tablet preparation method |
| CN107966519A (en) * | 2018-01-29 | 2018-04-27 | 威特(湖南)药业有限公司 | The detection method of impurity in HPLC analytical method and Telmisartan medicine |
| CN111265488A (en) * | 2020-03-18 | 2020-06-12 | 重庆康刻尔制药有限公司 | Telmisartan tablets and preparation method thereof |
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Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN107137370A (en) * | 2017-04-01 | 2017-09-08 | 重庆康刻尔制药有限公司 | A kind of telmisartan tablet preparation method |
| CN107966519A (en) * | 2018-01-29 | 2018-04-27 | 威特(湖南)药业有限公司 | The detection method of impurity in HPLC analytical method and Telmisartan medicine |
| CN111265488A (en) * | 2020-03-18 | 2020-06-12 | 重庆康刻尔制药有限公司 | Telmisartan tablets and preparation method thereof |
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