CN101738455B - 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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- CN101738455B CN101738455B CN 200810236312 CN200810236312A CN101738455B CN 101738455 B CN101738455 B CN 101738455B CN 200810236312 CN200810236312 CN 200810236312 CN 200810236312 A CN200810236312 A CN 200810236312A CN 101738455 B CN101738455 B CN 101738455B
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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, and is high to the blood vessel selectivity, expansible coronary artery and peripheral vascular, and 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, without postural hypotension; The long-term taking curative effect does not subtract, without cumulative effect.
Atenolol belongs to selectivity β1-receptor retarding agent, without intrinsic sympathomimetic acitivity, without the effect of quinine fourth sample myocardiac inhibition, does not pass 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 production run of medicine, 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 to be measured in this area.
Summary of the invention
The invention provides the method for measuring the dissolution rate of 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 with the potpourri of methyl alcohol and ammonium dibasic phosphate solution as mobile phase and measure the amount of nitrendipine and atenolol by high performance liquid chromatography as the detection wavelength take 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 measuring is that the weight ratio of wherein nitrendipine and atenolol is the compound of 2:1.In a preferred embodiment, the compound of measuring is composite tablet, contains atenolol 10mg, nitrendipine 5mg in every.
The invention provides the method for measuring the dissolution rate of 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 with the potpourri of methyl alcohol and ammonium dibasic phosphate solution as mobile phase and measure the amount of nitrendipine and atenolol by high performance liquid chromatography as the detection wavelength take 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 the 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 in contrast product solution I of solution that every 1ml contains the 0.2mg atenolol; It is an amount of that precision takes by weighing the nitrendipine reference substance in addition, adds ethanol and make in contrast product solution II of solution that every 1ml contains the 0.1mg nitrendipine; 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; Take methyl alcohol---0.02mol ammonium dibasic phosphate solution (volume ratio: 75:25) be mobile 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, the injection liquid chromatography records chromatogram respectively.By the stripping quantity of external standard method with every middle atenolol of calculated by peak area and nitrendipine.
The below provides embodiment to further specify the present invention, and 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 nitrendipine and the atenolol compound tablet of above-mentioned each lot number, according to dissolution method in the pharmacopeia (two appendix XC the 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 turns, 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 in contrast product solution I of solution that every 1ml contains the 0.2mg atenolol; It is an amount of that precision takes by weighing the nitrendipine reference substance in addition, adds ethanol and make in contrast product solution II of solution that every 1ml contains the 0.1mg nitrendipine; 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; Take methyl alcohol---0.02mol ammonium dibasic phosphate solution (volume ratio: 75:25) be mobile 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, the injection liquid chromatography records chromatogram respectively.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 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 (4)
1. dissolution detection method 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 measure the amount of nitrendipine and atenolol as detecting wavelength by high performance liquid chromatography as mobile phase and take 235nm with the potpourri of methyl alcohol and ammonium dibasic phosphate solution, concrete steps are as follows:
(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 in contrast product solution I of solution that every 1ml contains the 0.2mg atenolol; It is an amount of that precision takes by weighing the nitrendipine reference substance in addition, adds ethanol and make in contrast product solution II of solution that every 1ml contains the 0.1mg nitrendipine; 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, be filling agent with octadecylsilane chemically bonded silica; Take methyl alcohol-0.02mol ammonium dibasic phosphate solution as mobile 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, the injection liquid chromatography records chromatogram respectively; By the stripping quantity of external standard method with every middle atenolol of calculated by peak area and nitrendipine.
2. method according to claim 1, the volume ratio of methyl alcohol and ammonium dibasic phosphate solution is 75: 25.
3. method according to claim 1 and 2, the compound of wherein measuring are that the weight ratio of wherein nitrendipine and atenolol is 2: 1 compound.
4. method according to claim 3, the compound of wherein measuring is composite tablet, contains atenolol 10mg, nitrendipine 5mg in every.
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| CN1213538A (en) * | 1997-10-06 | 1999-04-14 | 沈阳药科大学 | Method of preparing fast-releasing and slowly-releasing solid dispersion micropill in liquid phase |
| 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 |
| CN1600296A (en) * | 2003-09-22 | 2005-03-30 | 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 |
| CN1847842A (en) * | 2006-04-14 | 2006-10-18 | 张宏业 | Joint measurement method of nitrendipine and atenolol |
| CN101034084A (en) * | 2007-03-23 | 2007-09-12 | 山东省医药工业研究所 | Method for detecting dissolution of memantine hydrochloride related preparations |
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Patent Citations (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1213538A (en) * | 1997-10-06 | 1999-04-14 | 沈阳药科大学 | Method of preparing fast-releasing and slowly-releasing solid dispersion micropill in liquid phase |
| CN1600296A (en) * | 2003-09-22 | 2005-03-30 | 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 |
| CN1847842A (en) * | 2006-04-14 | 2006-10-18 | 张宏业 | Joint measurement method of nitrendipine and atenolol |
| CN101034084A (en) * | 2007-03-23 | 2007-09-12 | 山东省医药工业研究所 | Method for detecting dissolution of memantine hydrochloride related preparations |
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| 张玉龙.提高难溶性药物尼群地平溶出率和口服生物利用度的研究.《沈阳药科大学学报》.2007,第24卷(第1期),1-8. * |
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