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分光光度法和反相高效液相色谱法同时测定复方片剂剂型中草酸艾司西酞普兰和氯硝西泮的含量

Spectrophotometric and reversed-phase high-performance liquid chromatographic methods for simultaneous determination of escitalopram oxalate and clonazepam in combined tablet dosage form.

作者信息

Gandhi Santosh Vilashchand, Dhavale Nilesh Dnyandev, Jadhav Vijay Yeshawantrao, Sabnis Shweta Sadanand

机构信息

All India Shri Shivaji Memorial Society's (AISSMS) College of Pharmacy, Department of Pharmaceutical Analysis, Kennedy Rd, Near RTO, Pune, Maharashtra, India.

出版信息

J AOAC Int. 2008 Jan-Feb;91(1):33-8.

Abstract

Simple, accurate, precise, and sensitive ultraviolet spectrophotometric and reversed-phase high-performance liquid chromatographic (RP-HPLC) methods for simultaneous estimation of escitalopram oxalate (ESC) and clonazepam (CLO) in combined tablet dosage form have been developed and validated. The spectroscopic method employs an absorbance correction method using 238.6 and 308 nm as 2 wavelengths for estimation with methanol and water as solvents. Beer's law is obeyed in the concentration range of 10.0-50.0 and 0.5-3.0 micro/mL for ESC and CLO, respectively. The RP-HPLC method uses a Jasco HPLC system with HiQ SiL C18 column (250 x 4.6 mm id) acetonitrile-0.005 M tetrabutylammonium hydrogen sulfate (55 + 45, v/v) as the mobile phase, and satranidazole as an internal standard. The detection was carried out using an ultraviolet detector set at 287 nm. For the HPLC method, Beer's law is obeyed in the concentration range of 10.0-60.0 and 0.5-3.0 microg/mL for ESC and CLO, respectively. Both methods have been successfully applied for the analysis of the drugs in a pharmaceutical formulation. Results of analysis were validated statistically and by recovery studies.

摘要

已开发并验证了简单、准确、精密且灵敏的紫外分光光度法和反相高效液相色谱法(RP-HPLC),用于同时测定复方片剂剂型中草酸艾司西酞普兰(ESC)和氯硝西泮(CLO)的含量。分光光度法采用吸光度校正法,以甲醇和水为溶剂,使用238.6和308 nm作为两个波长进行测定。ESC和CLO分别在10.0 - 50.0和0.5 - 3.0微克/毫升的浓度范围内符合比尔定律。RP-HPLC法使用Jasco HPLC系统,配备HiQ SiL C18柱(250×4.6 mm内径),以乙腈 - 0.005 M硫酸氢四丁铵(55 + 45,v/v)为流动相,并以塞曲司特作为内标。使用设定在287 nm的紫外检测器进行检测。对于HPLC法,ESC和CLO分别在10.0 - 60.0和0.5 - 3.0微克/毫升的浓度范围内符合比尔定律。两种方法均已成功应用于药物制剂中药物的分析。分析结果通过统计学方法和回收率研究进行了验证。

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