CN110057943A - A kind of efficient liquid phase chromatographic analysis detection method of Amlodipine Besylate Tablet intermediate - Google Patents
A kind of efficient liquid phase chromatographic analysis detection method of Amlodipine Besylate Tablet intermediate Download PDFInfo
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Abstract
A kind of efficient liquid phase chromatographic analysis detection method of Amlodipine Besylate Tablet intermediate phthalimide provided by the invention, this method is advantageously implemented the control in production process and storage to finished product and its key intermediary matter quality, have easy to operate, the advantages of accuracy is high, precision is high, stability and reproducibility are good, high sensitivity.
Description
Technical field
The present invention relates to a kind of efficient liquid phase chromatographic analysis detection sides of Amlodipine Besylate Tablet intermediate phthalimide
Method belongs to Pharmaceutical Analysis technical field.
Background technique
Hypertension (Hypertension), which refers to, to be increased with systemic arterial blood pressure (systolic pressure and/or diastolic pressure) as main feature
(systolic pressure >=140 millimetress of mercury, diastolic pressure >=90 millimetress of mercury), can be with the function or organic damage of the organs such as the heart, brain, kidney
Harmful clinical syndrome.Hypertension is the most common chronic disease and the most important risk factor of cardiovascular and cerebrovascular diseases.It is clinically high
Blood pressure can be divided into two classes: first is that essential hypertension, be one kind using blood pressure raising as main clinical manifestation and the cause of disease is not yet clear
Independent disease, 90% or more of Zhan Suoyou hypertensive patient.Second is that secondary hypertension, also known as symptomatic hypertension,
The cause of disease is clear in this kind of disease, and hypertension is only one of the clinical manifestation of this kind of disease, and blood pressure can the raising of temporary or persistence.
Currently used antihypertensive drugs can be summarized as five major class, i.e. diuretics, beta-blocker, angiotensin-converter
Enzyme inhibitor, hypertensinⅡreceptorretarder and calcium channel blocker (Calcium Channel blocker, abbreviation
CCB).According to the receptor-binding characteristic, tissue selectivity and pharmacokinetic characteristics of drug, CCB can be divided into three generations, wherein the
Three on behalf of Prolonged calcium antagonist, and using Amlodipine as representative, compared to two generation depressor before, outstanding advantages are partly to decline
Phase is long, has long-acting (1 time/d takes), and adverse reaction is small, convenient to take and the features such as can cover for 24 hours.
Amlodipine Besylate Tablet (Amlodipine Besylate), the wherein entitled 3- ethyl -5- methyl -2- of science of culture (2- ammonia second
Oxygen methyl) -4- (2- chlorphenyl)-Isosorbide-5-Nitrae-dihydro -6- methyl -3,5- pyridine dicarboxylate benzene sulfonate, molecular formula is
C20H25ClN2O5·C6H6O3S, molecular weight 567.1.
Its structural formula are as follows:
Wherein, benzene yellow acid Amlodipine has significant curative effect to treatment hypertension, in addition, as the joint of important component
Formulation examples are also repeatedly reported, including the stabilizing pharmaceutical composition CN105579031A containing Amlodipine and Valsartan；One
The pharmaceutical composition and its Ventricular Remodeling effect of kind Amlodipine Besylate Tablet, CN105777672A；A kind of compound Candesartan, ammonia
Flordipine granule and its preparation method, CN105919947A；A kind of preparation process of olmesartan medoxomil Amlodipine compound preparation,
CN105902510A；A kind of valsartan amlodipine medicine composition and preparation method thereof, CN104367574A, one kind containing benzene
The pharmaceutical composition of sulfonic acid Amlodipine, CN104415036A；Oral tablet containing Azilsartan and Amlodipine Besylate Tablet
And preparation method thereof, CN104644632A；Oral tablet and preparation method thereof containing Telmisartan and Amlodipine Besylate Tablet,
CN103271908A；A kind of compound system mixing the drug formed with Amlodipine Besylate Tablet and Hydrochioro with olmesartan medoxomil
Agent, CN102836161A etc..Therefore, Amlodipine Besylate Tablet has become a kind of effective depressor selection of wide spectrum.
Due to the synthesis process of above-mentioned Amlodipine Besylate Tablet, it is related to the Pureness control to intermediate phthalimide, it is adjacent
The presence of phthalic acid and phthalic anhydride techniques and the safety issue such as increases concerning related substance.
Therefore, for analysis detection being integrated with for process route of Amlodipine Besylate Tablet intermediate phthalimide
It is most important to close substance control, how simply, quickly, accurately intermediate phthalimide and its side reaction product are carried out
It efficiently separates, establishes the efficient analysis method of complete set, be that quality technology personnel face and solve the problems, such as.
Summary of the invention
The present invention provides a kind of detections of the efficient liquid phase chromatographic analysis of Amlodipine Besylate Tablet intermediate phthalimide
Method, chromatographic condition:
A. chromatographic column: DIONEXAcclaimOA organic acid analysis silica matrix column；
B. mobile phase: acetonitrile: phosphate aqueous solution (take phosphatase 24 00uL, water 10000mL is added to make to dissolve, filter)=(27~33):
(73~67) (V/V)；
C. flow velocity: 0.9~1.1mL/min；Column temperature: 33~37 DEG C；Sample volume: 10uL；
D.UV detector；Detection wavelength is 220nm；
E. solvent: acetonitrile；
Sample solution:
Test sample about 3mg is taken, it is accurately weighed, it is placed in 10mL measuring bottle, adds acetonitrile to dissolve and be diluted to scale, shake up, as confession
Test sample solution.
A kind of efficient liquid phase chromatographic analysis detection method of the Amlodipine Besylate Tablet intermediate, chromatographic condition:
A. chromatographic column: DIONEXAcclaimOA organic acid analysis silica matrix column；
B. mobile phase: acetonitrile: phosphate aqueous solution (takes phosphatase 24 00uL, water 10000mL is added to make to dissolve, filter)=30:70 (V/V)
C. flow velocity: 1.0mL/min；Column temperature: 35 DEG C；Sample volume: 10uL
D.UV detector；Detection wavelength is 220nm；
E. solvent: acetonitrile
The efficient liquid phase chromatographic analysis detection method of the Amlodipine Besylate Tablet intermediate, using reversed-phase high performance liquid chromatography
Areas of peak normalization method quantitative analysis.
The Amlodipine Besylate Tablet intermediate phthalimide of phthalic acid and phthalic anhydride will likely be contained
Test sample is passed through organic acid analysis silica matrix chromatogram column, is quantitatively divided using reversed-phase high performance liquid chromatography areas of peak normalization method
Analysis.
Measuring method: take test solution respectively in 0.9mL/min~1.1mL/min different in flow rate；Different column temperatures 33 DEG C~37
℃；Take different mobile phase ratio 28%~32% (V/V) acetonitriles, each sample introduction respectively at 35 DEG C of column temperature, flow velocity 1.0mL/min
10uL injects liquid chromatograph, records chromatogram, and content (retention time be main peak 4 times) is surveyed in normalization.
A kind of efficient liquid phase chromatographic analysis of Amlodipine Besylate Tablet intermediate phthalimide provided by the invention detects
Method, this method are advantageously implemented the control in production process and storage to finished product and its key intermediary matter quality, have
It is easy to operate, the advantages of accuracy is high, precision is high, stability and reproducibility are good, high sensitivity.
Detailed description of the invention
Fig. 1: Amlodipine Besylate Tablet intermediate phthalimide and related substance chromatographic peak positioning figure.Wherein, benzene sulfonic acid
It is Amlodipine intermediate phthalimide retention time 4.495 minutes, related substance phthalic acid 3.538 minutes, adjacent
Phthalate anhydride 11.153 minutes.
Specific embodiment
Above content according to the present invention is not departing from skill of the present invention according to the ordinary technical knowledge and customary means of this field
Under the premise of art thought, the modification of other diversified forms, replacement and change can also be made.
Form makees further supplementary explanation to above content by the following examples.
Embodiment 1
Experiment equipment and reagent
(1) laboratory apparatus:
Instrument: waters liquid chromatogram, Detection wavelength are as follows: 220nm
Flow velocity: 1mL/min
Column temperature: 33 DEG C
Sample volume: 10uL
Mobile phase: A: acetonitrile
B: phosphate aqueous solution (takes phosphatase 24 00uL, water 10000mL is added to make to dissolve, filter)
A:B=(30): (70) (V/V)
(3) experiment reagent:
Acetonitrile: Beijing lark prestige Science and Technology Ltd., HPLC grades；
Phosphoric acid: Chinese medicines group chemical reagent is analyzed pure
Implementation steps:
Precision measures 10 μ L of acetonitrile blank, injects liquid chromatograph, records chromatogram；As a result noiseless to impurity determination.It is accurate
Claim Amlodipine Besylate Tablet intermediate I (phthalimide) 3mg to be placed in 10mL volumetric flask, is dissolved and be diluted to acetonitrile
Scale is successively added dropwise the phthalic acid and appropriate phthalic anhydride of 1mg/mL, shakes up, as system suitability solution.It takes
System suitability solution sample introduction 10uL records chromatogram.Amlodipine Besylate Tablet intermediate phthalimide, O-phthalic
Acid, phthalic anhydride, separation is good, meets the requirements.
Embodiment 2
Experiment equipment and reagent
(1) laboratory apparatus:
Instrument: waters liquid chromatogram, Detection wavelength are as follows: 220nm
Flow velocity: 1mL/min
Column temperature: 35 DEG C
Sample volume: 10uL
Mobile phase: A: acetonitrile
B: phosphate aqueous solution (takes phosphatase 24 00uL, water 10000mL is added to make to dissolve, filter)
A:B=(30): (70) (V/V)
(3) experiment reagent:
Acetonitrile: Beijing lark prestige Science and Technology Ltd., HPLC grades；
Phosphoric acid: Chinese medicines group chemical reagent is analyzed pure
Implementation steps:
Precision measures 10 μ L of acetonitrile blank, injects liquid chromatograph, records chromatogram；As a result noiseless to impurity determination.It is accurate
Claim Amlodipine Besylate Tablet intermediate I (phthalimide) 3mg to be placed in 10mL volumetric flask, is dissolved and be diluted to acetonitrile
Scale is successively added dropwise the phthalic acid and appropriate phthalic anhydride of 1mg/mL, shakes up, as system suitability solution.It takes
System suitability solution sample introduction 10uL records chromatogram.Amlodipine Besylate Tablet intermediate phthalimide, O-phthalic
Acid, phthalic anhydride, separation is good, meets the requirements.
Embodiment 3
Experiment equipment and reagent
(1) laboratory apparatus:
Instrument: waters liquid chromatogram, Detection wavelength are as follows: 220nm
Flow velocity: 1mL/min
Column temperature: 37 DEG C
Sample volume: 10uL
Mobile phase: A: acetonitrile
B: phosphate aqueous solution (takes phosphatase 24 00uL, water 10000mL is added to make to dissolve, filter)
A:B=(30): (70) (V/V)
(3) experiment reagent:
Acetonitrile: Beijing lark prestige Science and Technology Ltd., HPLC grades；
Phosphoric acid: Chinese medicines group chemical reagent is analyzed pure
Implementation steps:
Precision measures 10 μ L of acetonitrile blank, injects liquid chromatograph, records chromatogram；As a result noiseless to impurity determination.It is accurate
Claim Amlodipine Besylate Tablet intermediate I (phthalimide) 3mg to be placed in 10mL volumetric flask, is dissolved and be diluted to acetonitrile
Scale is successively added dropwise the phthalic acid and appropriate phthalic anhydride of 1mg/mL, shakes up, as system suitability solution.It takes
System suitability solution sample introduction 10uL records chromatogram.Amlodipine Besylate Tablet intermediate phthalimide, O-phthalic
Acid, phthalic anhydride, separation is good, meets the requirements.
Embodiment 4
Experiment equipment and reagent
(1) laboratory apparatus:
Instrument: waters liquid chromatogram, Detection wavelength are as follows: 220nm
Flow velocity: 1mL/min
Column temperature: 35 DEG C
Sample volume: 10uL
Mobile phase: A: acetonitrile
B: phosphate aqueous solution (takes phosphatase 24 00uL, water 10000mL is added to make to dissolve, filter)
A:B=(27): (73) (V/V)
(3) experiment reagent:
Acetonitrile: Beijing lark prestige Science and Technology Ltd., HPLC grades；
Phosphoric acid: Chinese medicines group chemical reagent is analyzed pure
Implementation steps:
Precision measures 10 μ L of acetonitrile blank, injects liquid chromatograph, records chromatogram；As a result noiseless to impurity determination.It is accurate
Claim Amlodipine Besylate Tablet intermediate I (phthalimide) 3mg to be placed in 10mL volumetric flask, is dissolved and be diluted to acetonitrile
Scale is successively added dropwise the phthalic acid and appropriate phthalic anhydride of 1mg/mL, shakes up, as system suitability solution.It takes
System suitability solution sample introduction 10uL records chromatogram.Amlodipine Besylate Tablet intermediate phthalimide, O-phthalic
Acid, phthalic anhydride, separation is good, meets the requirements.
Embodiment 5
Experiment equipment and reagent
(1) laboratory apparatus:
Instrument: waters liquid chromatogram, Detection wavelength are as follows: 220nm
Flow velocity: 1mL/min
Column temperature: 35 DEG C
Sample volume: 10uL
Mobile phase: A: acetonitrile
B: phosphate aqueous solution (takes phosphatase 24 00uL, water 10000mL is added to make to dissolve, filter)
A:B=(33): (67) (V/V)
(3) experiment reagent:
Acetonitrile: Beijing lark prestige Science and Technology Ltd., HPLC grades；
Phosphoric acid: Chinese medicines group chemical reagent is analyzed pure
Implementation steps:
Precision measures 10 μ L of acetonitrile blank, injects liquid chromatograph, records chromatogram；As a result noiseless to impurity determination.It is accurate
Claim Amlodipine Besylate Tablet intermediate I (phthalimide) 3mg to be placed in 10mL volumetric flask, is dissolved and be diluted to acetonitrile
Scale is successively added dropwise the phthalic acid and appropriate phthalic anhydride of 1mg/mL, shakes up, as system suitability solution.It takes
System suitability solution sample introduction 10uL records chromatogram.Amlodipine Besylate Tablet intermediate phthalimide, O-phthalic
Acid, phthalic anhydride, separation is good, meets the requirements.
Embodiment 6
Experiment equipment and reagent
(1) laboratory apparatus:
Instrument: waters liquid chromatogram, Detection wavelength are as follows: 220nm
Flow velocity: 0.9mL/min
Column temperature: 35 DEG C
Sample volume: 10uL
Mobile phase: A: acetonitrile
B: phosphate aqueous solution (takes phosphatase 24 00uL, water 10000mL is added to make to dissolve, filter)
A:B=(30): (70) (V/V)
(3) experiment reagent:
Acetonitrile: Beijing lark prestige Science and Technology Ltd., HPLC grades；
Phosphoric acid: Chinese medicines group chemical reagent is analyzed pure
Implementation steps:
Precision measures 10 μ L of acetonitrile blank, injects liquid chromatograph, records chromatogram；As a result noiseless to impurity determination.It is accurate
Claim Amlodipine Besylate Tablet intermediate I (phthalimide) 3mg to be placed in 10mL volumetric flask, is dissolved and be diluted to acetonitrile
Scale is successively added dropwise the phthalic acid and appropriate phthalic anhydride of 1mg/mL, shakes up, as system suitability solution.It takes
System suitability solution sample introduction 10uL records chromatogram.Amlodipine Besylate Tablet intermediate phthalimide, O-phthalic
Acid, phthalic anhydride, separation is good, meets the requirements.
Embodiment 7
Experiment equipment and reagent
(1) laboratory apparatus:
Instrument: waters liquid chromatogram, Detection wavelength are as follows: 220nm
Flow velocity: 1.1mL/min
Column temperature: 35 DEG C
Sample volume: 10uL
Mobile phase: A: acetonitrile
B: phosphate aqueous solution (takes phosphatase 24 00uL, water 10000mL is added to make to dissolve, filter)
A:B=(30): (70) (V/V)
(3) experiment reagent:
Acetonitrile: Beijing lark prestige Science and Technology Ltd., HPLC grades；
Phosphoric acid: Chinese medicines group chemical reagent is analyzed pure
Implementation steps:
Precision measures 10 μ L of acetonitrile blank, injects liquid chromatograph, records chromatogram；As a result noiseless to impurity determination.It is accurate
Claim Amlodipine Besylate Tablet intermediate I (phthalimide) 3mg to be placed in 10mL volumetric flask, is dissolved and be diluted to acetonitrile
Scale is successively added dropwise the phthalic acid and appropriate phthalic anhydride of 1mg/mL, shakes up, as system suitability solution.It takes
System suitability solution sample introduction 10uL records chromatogram.Amlodipine Besylate Tablet intermediate phthalimide, O-phthalic
Acid, phthalic anhydride, separation is good, meets the requirements.
Embodiment 8
Experiment equipment and reagent
(1) laboratory apparatus:
Instrument: waters liquid chromatogram matches UV detector
(2) chromatographic condition:
Chromatographic column: DIONEXAcclaimOA organic acid analysis silica matrix column
Flow velocity: 1.0mL/min；
Detection wavelength is 220nm
Column temperature: 35 DEG C；
Sample volume: 10uL
Mobile phase:
A: acetonitrile B: phosphate aqueous solution (takes phosphatase 24 00uL, water 10000mL is added to make to dissolve, filter) A:B=(30): (70) (V/V)
(3) experiment reagent:
Acetonitrile: Beijing lark prestige Science and Technology Ltd., HPLC grades；
Phosphoric acid: Chinese medicines group chemical reagent is analyzed pure
Implementation steps:
Precision weighs phthalic acid, phthalic anhydride, phthalimide respectively, is dissolved with acetonitrile, and is respectively prepared
Every mL contains 193.8ug, and phthalic acid, phthalic anhydride, the acetonitrile of phthalimide of 195.2ug, 382.6ug are molten
Liquid, precision measure above-mentioned solution and obtain precision measurement solution with 50 times of dilution in acetonitrile.6 parts of measurement is weighed in parallel, calculates separately peak
The relative standard deviation of area, the results are shown in Table 1, and this law precision is good.
1 Precision test result of table
Claims (3)
1. a kind of efficient liquid phase chromatographic analysis detection method of Amlodipine Besylate Tablet intermediate, it is characterised in that: chromatographic condition:
A. chromatographic column: DIONEX AcclaimOA organic acid analysis silica matrix column；
B. mobile phase: acetonitrile: phosphate aqueous solution (take phosphatase 24 00uL, water 10000mL is added to make to dissolve, filter)=(27~33):
(73~67) (V/V)
C. flow velocity: 0.9~1.1mL/min；Column temperature: 33~37 DEG C；Sample volume: 10uL
D.UV detector；Detection wavelength is 220nm；
E. solvent: acetonitrile
Sample solution:
Test sample about 3mg is taken, it is accurately weighed, it is placed in 10mL measuring bottle, adds acetonitrile to dissolve and be diluted to scale, shake up, as confession
Test sample solution.
2. a kind of efficient liquid phase chromatographic analysis detection method of Amlodipine Besylate Tablet intermediate according to claim 1,
It is characterized by:
Chromatographic condition:
A. chromatographic column: DIONEX AcclaimOA organic acid analysis silica matrix column；
B. mobile phase: acetonitrile: phosphate aqueous solution (takes phosphatase 24 00uL, water 10000mL is added to make to dissolve, filter)=30:70 (V/V)
C. flow velocity: 1.0mL/min；Column temperature: 35 DEG C；Sample volume: 10uL
D.UV detector；Detection wavelength is 220nm；
E. solvent: acetonitrile
Sample solution:
Test sample about 3mg is taken, it is accurately weighed, it is placed in 10mL measuring bottle, adds acetonitrile to dissolve and be diluted to scale, shake up, as confession
Test sample solution.
3. the efficient liquid phase chromatographic analysis detection method of Amlodipine Besylate Tablet intermediate according to claim 1 or 2,
It is characterized in that using the quantitative analysis of reversed-phase high performance liquid chromatography areas of peak normalization method.
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN114609289A (en) * | 2022-02-24 | 2022-06-10 | 云南龙津康佑生物医药有限公司 | Method for detecting impurities in olmesartan medoxomil and amlodipine compound preparation |
| CN115308326A (en) * | 2022-08-05 | 2022-11-08 | 四川尚锐分析检测有限公司 | Method for detecting telmisartan amlodipine in blood plasma by LC-MS (liquid chromatography-mass spectrometry) method |
-
2019
- 2019-05-24 CN CN201910438375.9A patent/CN110057943A/en not_active Withdrawn
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN114609289A (en) * | 2022-02-24 | 2022-06-10 | 云南龙津康佑生物医药有限公司 | Method for detecting impurities in olmesartan medoxomil and amlodipine compound preparation |
| CN114609289B (en) * | 2022-02-24 | 2023-11-14 | 云南龙津康佑生物医药有限公司 | Method for detecting impurities in olmesartan medoxomil amlodipine compound preparation |
| CN115308326A (en) * | 2022-08-05 | 2022-11-08 | 四川尚锐分析检测有限公司 | Method for detecting telmisartan amlodipine in blood plasma by LC-MS (liquid chromatography-mass spectrometry) method |
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Application publication date: 20190726 |