CN101738455A - Dissolution detection method of nitrendipine and atenolol compound composition - Google Patents
Dissolution detection method of nitrendipine and atenolol compound composition Download PDFInfo
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- CN101738455A CN101738455A CN200810236312A CN200810236312A CN101738455A CN 101738455 A CN101738455 A CN 101738455A CN 200810236312 A CN200810236312 A CN 200810236312A CN 200810236312 A CN200810236312 A CN 200810236312A CN 101738455 A CN101738455 A CN 101738455A
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Abstract
The invention provides a method for measuring the dissolution of a nitrendipine and atenolol compound composition through a high-efficiency liquid chromatography method. The method comprises the following steps of: by using a lauryl sodium sulfate solution as a dissolution medium, dissolving out the compound composition; and by using a mixture of methanol and a diammonium hydrogen phosphate solution as a mobile phase, measuring the dissolution amount of nitrendipine and atenolol through the high-efficiency liquid chromatography method by using a detection wavelength of 235nm.
Description
Technical field
The present invention relates to medical technical field, more particularly, the present invention relates to the dissolution detection method of nitrendipine and atenolol compound composition.
Background technology
Nitrendipine is a kind of bihydropyridine type calcium antagonist, to blood vessel selectivity height, and expansible coronary artery and peripheral vascular, rapid-action, safety, gentleness, lasting, the less water-sodium retention that occurs can reduce myocardial consumption of oxygen, and ischemic myocardium is had protective effect; The heart rate reflectivity can occur when heavy dose of and speed no postural hypotension; Take curative effect for a long time and do not subtract, no cumulative effect.
Atenolol belongs to selectivity β1-Shou Ti retarding agent, no intrinsic sympathomimetic acitivity, and no quinine fourth sample cardiac muscle inhibiting effect is not passed through blood-brain barrier; Be used for the treatment of hypertension, angina pectoris and arrhythmia cordis.
Nitrendipine and atenolol are made compound medicine treats hypertension, angina pectoris and arrhythmia cordis etc. and has obtained good efficacy.In the medicine production process, dissolution rate that need to measure active component in the medicine has good efficacy when clinical to guarantee to be used for.For nitrendipine and atenolol compound medicine, the effective ways of these two kinds of active components dissolution rate separately need be measured in this area.
Summary of the invention
The invention provides the method for dissolution of measuring nitrendipine and atenolol compound composition by high performance liquid chromatography, described method comprises uses sodium dodecyl sulfate solution to carry out the stripping of compound as dissolution medium, and to use the potpourri of methyl alcohol and ammonium dibasic phosphate solution be to detect wavelength and the amount of measuring nitrendipine and atenolol by high performance liquid chromatography as moving phase and with 235nm.
In a preferred embodiment, the concentration of ammonium dibasic phosphate solution is 0.02mol/L.
In another preferred embodiment, the volume ratio of methyl alcohol and ammonium dibasic phosphate solution is 75: 25.
In another preferred embodiment, dissolution medium is 1.0% sodium dodecyl sulfate solution.
In another preferred embodiment, the compound of being measured is that the weight ratio of wherein nitrendipine and atenolol is 2: 1 a compound.In a preferred embodiment, the compound of being measured is a composite tablet, contains atenolol 10mg, nitrendipine 5mg in every.
Summary of the invention
The invention provides the method for dissolution of measuring nitrendipine and atenolol compound composition by high performance liquid chromatography, described method comprises uses sodium dodecyl sulfate solution to carry out the stripping of compound as dissolution medium, and to use the potpourri of methyl alcohol and ammonium dibasic phosphate solution be to detect wavelength and the amount of measuring nitrendipine and atenolol by high performance liquid chromatography as moving phase and with 235nm.
In a specific embodiment, the inventive method may further comprise the steps:
1. lucifuge operation.
Get nitrendipine and atenolol compound composition, according to dissolution method in the pharmacopeia (two appendix XC second methods of Chinese Pharmacopoeia version in 2005), with 1.0% sodium dodecyl sulfate solution as dissolution medium, carry out the stripping operation, in the time of 45 minutes, get solution and filter, with filtrate as need testing solution, it is an amount of that precision takes by weighing the atenolol reference substance, adds the stripping medium and make solution that every 1ml contains 0.2mg atenolol product solution I in contrast; It is an amount of that precision takes by weighing the nitrendipine reference substance in addition, adds ethanol and make solution that every 1ml contains 0.1mg nitrendipine product solution II in contrast; Precision is measured two kinds of each 5ml of reference substance solution and is placed same 100ml measuring bottle, adds above-mentioned dissolution medium and is diluted to scale, shakes up, in contrast product solution.
2. according to high performance liquid chromatography (two appendix VD of Chinese Pharmacopoeia version in 2005), be filling agent with octadecylsilane chemically bonded silica; With methyl alcohol-0.02mol ammonium dibasic phosphate solution (volume ratio: 75: 25) is moving phase; The detection wavelength is 235nm; Flow velocity is 1.0ml/ minute; Column temperature is 35 ℃; Theoretical cam curve is calculated by the atenolol peak and is not less than 1000, and atenolol peak and nitrendipine peak degree of separation should be greater than 3.0; Get each 20 μ l of reference substance solution and need testing solution, inject liquid chromatograph respectively, the record chromatogram.By the stripping quantity of external standard method with every middle atenolol of calculated by peak area and nitrendipine.
Provide embodiment to further specify the present invention below, embodiment just illustrates the present invention, rather than limitation of the present invention.
Embodiment
Nitrendipine and atenolol compound tablet that use derives from Jiangsu Ji Beier Medicine Co.,Ltd carry out dissolution determination.(every contains nitrendipine 4.9mg to described tablet lot number 20041012, contain atenolol 10.0mg, sheet heavily is 0.0854g), 060801 (every contains nitrendipine 5.1mg, contain atenolol 9.7mg, sheet heavily is 0.0863g), 060802 (every contains nitrendipine 5.1mg, contains atenolol 9.8mg, sheet heavily is 0.0860g), 060803 (every contains nitrendipine 5.1mg, contains atenolol 9.8mg, and sheet heavily is 0.0866g).
1. lucifuge operation.
Get the nitrendipine and the atenolol compound tablet of above-mentioned each lot number, according to dissolution method in the pharmacopeia (two appendix XC second methods of Chinese Pharmacopoeia version in 2005), with 1.0% lauryl sodium sulfate aqueous solution 1000ml as dissolution medium (1 is dissolved in the 1000ml dissolution medium), rotating speed is that per minute 75 changes, carry out the stripping operation, in the time of 45 minutes, getting solution filters, with filtrate 50ml as need testing solution, it is an amount of that precision takes by weighing the atenolol reference substance, adds the stripping medium and make solution that every 1ml contains 0.2mg atenolol product solution I in contrast; It is an amount of that precision takes by weighing the nitrendipine reference substance in addition, adds ethanol and make solution that every 1ml contains 0.1mg nitrendipine product solution II in contrast; Precision is measured two kinds of each 5ml of reference substance solution and is placed same 100ml measuring bottle, adds above-mentioned dissolution medium and is diluted to scale, shakes up, in contrast product solution.
2. according to high performance liquid chromatography (two appendix VD of Chinese Pharmacopoeia version in 2005), be filling agent with octadecylsilane chemically bonded silica; With methyl alcohol-0.02mol ammonium dibasic phosphate solution (volume ratio: 75: 25) is moving phase; The detection wavelength is 235nm; Flow velocity is 1.0ml/ minute; Column temperature is 35 ℃; Theoretical cam curve is calculated by the atenolol peak and is not less than 1000, and atenolol peak and nitrendipine peak degree of separation should be greater than 3.0; Get each 20 μ l of reference substance solution and need testing solution, inject liquid chromatograph respectively, the record chromatogram.By the stripping quantity of external standard method with every middle atenolol of calculated by peak area and nitrendipine.Measurement result sees the following form:
Table 1: atenolol dissolution determination result in nitrendipine and the atenolol compound tablet
Table 2: Nitrendipine Dissolution measurement result in nitrendipine and the atenolol compound tablet
The dissolution rate limit is defined as: the limit of atenolol is 80% of a labelled amount, and the limit of nitrendipine is that 75% of labelled amount is rational.
The above results shows that the inventive method is feasible.
Claims (7)
1. method of dissolution of measuring nitrendipine and atenolol compound composition by high performance liquid chromatography, described method comprises: use sodium dodecyl sulfate solution to carry out the stripping of compound as dissolution medium, and to use the potpourri of methyl alcohol and ammonium dibasic phosphate solution be to detect wavelength and the amount of measuring nitrendipine and atenolol by high performance liquid chromatography as moving phase and with 235nm.
2. method according to claim 1, wherein the concentration of ammonium dibasic phosphate solution is 0.02mol/L.
3. method according to claim 1 and 2, the volume ratio of methyl alcohol and ammonium dibasic phosphate solution are 75: 25.
4. according to claim 1,2 or 3 described methods, wherein dissolution medium is 1.0% sodium dodecyl sulfate solution.
5. according to the described method of claim 1-4, wherein the compound of being measured is that the weight ratio of wherein nitrendipine and atenolol is 2: 1 a compound.
6. method according to claim 5, wherein the compound of being measured is a composite tablet, contains atenolol 10mg, nitrendipine 5mg in every.
7. method according to claim 1, wherein said method may further comprise the steps:
(1) lucifuge operation;
Get nitrendipine and atenolol compound composition, according to dissolution method in the Chinese Pharmacopoeia, with 1.0% sodium dodecyl sulfate solution as dissolution medium, carry out the stripping operation, in the time of 45 minutes, get solution and filter, with filtrate as need testing solution, it is an amount of that precision takes by weighing the atenolol reference substance, adds the stripping medium and make solution that every 1ml contains 0.2mg atenolol product solution I in contrast; It is an amount of that precision takes by weighing the nitrendipine reference substance in addition, adds ethanol and make solution that every 1ml contains 0.1mg nitrendipine product solution II in contrast; Precision is measured two kinds of each 5ml of reference substance solution and is placed same 100ml measuring bottle, adds above-mentioned dissolution medium and is diluted to scale, shakes up, in contrast product solution;
(2) according to high performance liquid chromatography (two appendix VD of Chinese Pharmacopoeia version in 2005), be filling agent with octadecylsilane chemically bonded silica; With methyl alcohol-0.02mol ammonium dibasic phosphate solution (volume ratio: 75: 25) is moving phase; The detection wavelength is 235nm; Flow velocity is 1.0ml/ minute; Column temperature is 35 ℃; Theoretical cam curve is calculated by the atenolol peak and is not less than 1000, and atenolol peak and nitrendipine peak degree of separation should be greater than 3.0; Get each 20 μ l of reference substance solution and need testing solution, inject liquid chromatograph respectively, the record chromatogram; By the stripping quantity of external standard method with every middle atenolol of calculated by peak area and nitrendipine.
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN107449844A (en) * | 2017-08-30 | 2017-12-08 | 合肥立方制药股份有限公司 | A kind of method for determining Succimer preparation dissolution rate |
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| CN1159001C (en) * | 1997-10-06 | 2004-07-28 | 沈阳药科大学 | Method of preparing fast-releasing and slowly-releasing solid dispersion micropill in liquid phase |
| CN100379406C (en) * | 2003-09-22 | 2008-04-09 | 北京德众万全药物技术开发有限公司 | Method for preparing tiny pellets of difficult soluble drugs and formulation containing the pellets |
| CN1559407A (en) * | 2004-02-23 | 2005-01-05 | 沈阳药科大学 | Self-micro emulsion solft capsule of dihydropyridine type calcium ion agonist, and its prepn. method |
| CN100401058C (en) * | 2006-04-14 | 2008-07-09 | 张宏业 | Joint measurement method of nitrendipine and atenolol |
| CN100547400C (en) * | 2007-03-23 | 2009-10-07 | 山东省医药工业研究所 | The dissolution detection method of memantine hydrochloride related preparations |
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| CN107449844A (en) * | 2017-08-30 | 2017-12-08 | 合肥立方制药股份有限公司 | A kind of method for determining Succimer preparation dissolution rate |
| CN107449844B (en) * | 2017-08-30 | 2020-05-08 | 合肥立方制药股份有限公司 | Method for determining dissolution rate of dimercaptosuccinic acid preparation |
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