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采用高效液相色谱(反相高效液相色谱法,RP-HPLC)同时测定药物制剂中苯磺酸氨氯地平和吲达帕胺的含量。

Simultaneous Estimation of Amlodipine Besylate and Indapamide in a Pharmaceutical Formulation by a High Performance Liquid Chromatographic (RP-HPLC) Method.

作者信息

Patel Deval B, Mehta Falgun A, Bhatt Kashyap K

机构信息

Department of Pharmaceutical Chemistry and Analysis, Indukaka Ipcowala College of Pharmacy, New Vallabh Vidyanagar - 388121, Gujarat, India.

出版信息

Sci Pharm. 2012 Jul-Sep;80(3):581-90. doi: 10.3797/scipharm.1203-07. Epub 2012 Apr 30.

DOI:10.3797/scipharm.1203-07
PMID:23008807
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC3447622/
Abstract

An isocratic reversed-phase liquid chromatograpic assay method was developed for the quantitative determination of amlodipine besylate (AML) and indapamide (IND) in combined dosage form. A Brownlee C-18, 5 μm column with a mobile phase containing 0.02 M potassium dihydrogen phosphate-methanol (30+70, v/v) total pH-adjusted to 3 using o-phosphoric acid was used. The flow rate was 1.0 mL min(-1) and effluents were monitored at 242 nm. The retention times of amlodipine besylate and indapamide were 5.9 min and 3.6 min, respectively. The proposed method was validated with respect to linearity, accuracy, precision, and robustness. The method was successfully applied to the estimation of amlodipine besylate and indapamide in combined tablet dosage forms.

摘要

建立了一种等度反相液相色谱分析方法,用于定量测定复方制剂中苯磺酸氨氯地平(AML)和吲达帕胺(IND)的含量。使用Brownlee C-18、5μm柱,流动相为含0.02M磷酸二氢钾-甲醇(30+70,v/v),用邻磷酸将总体pH调至3。流速为1.0 mL min(-1),在242nm处监测流出物。苯磺酸氨氯地平和吲达帕胺的保留时间分别为5.9分钟和3.6分钟。该方法在线性、准确度、精密度和稳健性方面得到了验证。该方法成功应用于复方片剂剂型中苯磺酸氨氯地平和吲达帕胺的测定。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d6b4/3447622/c62b95331b3c/scipharm-2012-80-581f2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d6b4/3447622/69a6c82723f1/scipharm-2012-80-581f1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d6b4/3447622/c62b95331b3c/scipharm-2012-80-581f2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d6b4/3447622/69a6c82723f1/scipharm-2012-80-581f1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d6b4/3447622/c62b95331b3c/scipharm-2012-80-581f2.jpg

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本文引用的文献

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Chem Pharm Bull (Tokyo). 2007 Feb;55(2):241-6. doi: 10.1248/cpb.55.241.
2
Stability indicating RP-HPLC method for simultaneous determination of amlodipine and benazepril hydrochloride from their combination drug product.用于同时测定复方制剂中氨氯地平和盐酸贝那普利的稳定性指示反相高效液相色谱法。
J Pharm Biomed Anal. 2005 Sep 1;39(1-2):147-55. doi: 10.1016/j.jpba.2005.04.001.
Development and Validation of highly Sensitive Stability Indicating Spectrofluorimetric Method for Determination of Amlodipine in Pharmaceutical Preparations and Human Plasma.
用于测定药物制剂和人血浆中氨氯地平的高灵敏度稳定性指示荧光分光光度法的开发与验证
J Fluoresc. 2016 Nov;26(6):2141-2149. doi: 10.1007/s10895-016-1910-4. Epub 2016 Aug 26.