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验证的反相高效液相色谱法同时测定原料药和制剂中氯沙坦钾和美托拉宗的含量

Validated RP-HPLC Method for Simultaneous Quantitation of Losartan Potassium and Metolazone in Bulk Drug and Formulation.

作者信息

Dubey Ramkumar, Bhusari Vidhya K, Dhaneshwar Sunil R

机构信息

Department of Pharmaceutical Chemistry, Bharati Vidyapeeth University, Poona College of Pharmacy, Pune, Maharashtra, 411038, India.

出版信息

Sci Pharm. 2011 Jul-Sep;79(3):545-54. doi: 10.3797/scipharm.1105-13. Epub 2011 Jun 26.

DOI:10.3797/scipharm.1105-13
PMID:21886902
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC3163373/
Abstract

A HPLC method has been described for simultaneous determination of Losartan potassium and Metolazone in formulation. This method is based on a HPLC separation of the two drugs on the Thermo Hypersil BDS-C(18) (250 mm × 4.6 mm, 5.0 μm) with isocratic conditions and a simple mobile phase containing acetonitrile:water (60:40) at a flow rate of 0.8 mL/min using UV detection at 237 nm. This method has been applied to a marketed formulation without interference of excipients. The linear regression analysis data for the calibration plots showed a good linear relationship over the concentration range of 2-12 μg/mL for Losartan potassium and 0.2-1.2 μg/mL for Metolazone, respectively. The method was validated for precision, robustness and recovery. Statistical analysis showed that the method is repeatable and selective for the estimation of Losartan potassium and Metolazone.

摘要

已描述了一种用于同时测定制剂中氯沙坦钾和美托拉宗的高效液相色谱法。该方法基于在Thermo Hypersil BDS-C(18)(250 mm×4.6 mm,5.0μm)上对两种药物进行高效液相色谱分离,采用等度条件,流动相为简单的乙腈:水(60:40),流速为0.8 mL/min,在237 nm处进行紫外检测。该方法已应用于市售制剂,未受到辅料的干扰。校准曲线的线性回归分析数据表明,氯沙坦钾在2 - 12μg/mL浓度范围内,美托拉宗在0.2 - 1.2μg/mL浓度范围内分别呈现良好的线性关系。该方法在精密度、稳健性和回收率方面得到了验证。统计分析表明,该方法对于氯沙坦钾和美托拉宗的测定具有可重复性和选择性。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a2db/3163373/106dc93b6948/Scipharm-2011-79-545f3.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a2db/3163373/396ee6fa24bc/Scipharm-2011-79-545f1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a2db/3163373/b1d9f5c8ec42/Scipharm-2011-79-545f2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a2db/3163373/106dc93b6948/Scipharm-2011-79-545f3.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a2db/3163373/396ee6fa24bc/Scipharm-2011-79-545f1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a2db/3163373/b1d9f5c8ec42/Scipharm-2011-79-545f2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a2db/3163373/106dc93b6948/Scipharm-2011-79-545f3.jpg

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本文引用的文献

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Determination of metolazone in human blood by liquid chromatography with electrospray ionization tandem mass spectrometry.采用液相色谱-电喷雾电离串联质谱法测定人血液中的美托拉宗。
J Chromatogr B Analyt Technol Biomed Life Sci. 2007 Jan 1;845(1):169-73. doi: 10.1016/j.jchromb.2006.07.033. Epub 2006 Aug 14.
2
Analysis of binary mixtures of losartan potassium and hydrochlorothiazide by using high performance liquid chromatography, ratio derivative spectrophotometric and compensation technique.采用高效液相色谱法、比率导数分光光度法和补偿技术对氯沙坦钾和氢氯噻嗪二元混合物进行分析。
J Pharm Biomed Anal. 2001 Feb;24(4):603-11. doi: 10.1016/s0731-7085(00)00434-9.
通过高效薄层色谱法灵敏且准确地测定氯沙坦钾制剂。
Pharm Methods. 2011 Apr;2(2):95-8. doi: 10.4103/2229-4708.84444.