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采用导数分光光度法同时测定片剂中醋酸环丙孕酮和炔雌醇的含量。

Simultaneous determination of cyproterone acetate and ethinylestradiol in tablets by derivative spectrophotometry.

作者信息

Souri Effat, Jalalizadeh Hassan, Farsam Hassan, Ghadiri Roksana, Amanlou Massoud

机构信息

Department of Medicinal Chemistry, Faculty of Pharmacy and Pharmaceutical Research Center, Tehran University of Medical Sciences, Tehran (14155-6451), Iran.

出版信息

Chem Pharm Bull (Tokyo). 2005 Aug;53(8):949-51. doi: 10.1248/cpb.53.949.

DOI:10.1248/cpb.53.949
PMID:16079526
Abstract

Derivative spectrophotometry offers a useful approach for the analysis of drugs in multi-component mixtures. In this study a third-derivative spectrophotometric method was used for simultaneous determination of cyproterone acetate and ethinylestradiol using the zero-crossing technique. The measurements were carried out at wavelengths of 316 and 226 nm for cyproterone acetate and ethinylestradiol respectively. The method was found to be linear (r2>0.999) in the range of 0.5-6 mg/100 ml for cyproterone acetate in the presence of 35 microg/100 ml ethinylestsradiol at 316 nm. The same linear correlation (r2>0.999) was obtained in the range of 10-80 microg/100 ml of ethinylestradiol in the presence of 2 mg/100 ml of cyproterone acetate at 226 nm. The limit of determination was 0.5 mg/100 ml and 10 microg/100 ml for cyproterone acetate and ethinylestradiol respectively. The method was successfully applied for simultaneous determination of cyproterone acetate and ethinylestradiol in pharmaceutical preparations without any interferences from excipients.

摘要

导数分光光度法为多组分混合物中的药物分析提供了一种有用的方法。在本研究中,采用三阶导数分光光度法,利用零交叉技术同时测定醋酸环丙孕酮和炔雌醇。分别在316 nm和226 nm波长处对醋酸环丙孕酮和炔雌醇进行测量。结果发现,在316 nm波长下,当存在35 μg/100 ml炔雌醇时,醋酸环丙孕酮在0.5 - 6 mg/100 ml范围内呈线性(r2>0.999)。在226 nm波长下,当存在2 mg/100 ml醋酸环丙孕酮时,炔雌醇在10 - 80 μg/100 ml范围内也获得了相同的线性相关性(r2>0.999)。醋酸环丙孕酮和炔雌醇的测定限分别为0.5 mg/100 ml和10 μg/100 ml。该方法成功应用于药物制剂中醋酸环丙孕酮和炔雌醇的同时测定,且不受辅料的干扰。

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