紫外分光光度法测定盐酸吡格列酮原料药和制剂含量的分析方法建立与验证

K. Bhavyasri, R. Sai Chandana, M. Sumakanth, R. Swethasri
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引用次数: 1

摘要

请引用这篇文章:Bhavyasri K等人,紫外分光光度法测定盐酸吡格列酮原料药和制剂的分析方法开发与验证。美国医药技术研究杂志2019。杨建平,杨建平,李建平,等。紫外分光光度法测定盐酸吡格列酮原厂和制剂中含量的方法建立及验证[j]。摘要建立了一种可靠的紫外光谱法测定盐酸吡格列酮含量的方法。盐酸吡格列酮的最大吸收波长分别为268nm。盐酸吡格列酮在10 ~ 50μg/ml范围内呈线性关系,相关系数为0.999。对盐酸吡格列酮进行精密度分析,发现精密度值小于2。本法结果令人满意,适用于原料药和制剂常规质量控制中盐酸吡格列酮的含量测定。该方法按照ICH指南Q2R1进行验证。
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Analytical Method Development and Validation for The Estimation of Pioglitazone Hydrochloride in Bulk and Formulation by UV-Spectrophotometry
Please cite this article as: Bhavyasri K et al., Analytical Method Development and Validation for The Estimation of Pioglitazone Hydrochloride in Bulk and Formulation by UV-Spectrophotometry. American Journal of PharmTech Research 2019. Analytical Method Development and Validation for The Estimation of Pioglitazone Hydrochloride in Bulk and Formulation by UVSpectrophotometry K. Bhavyasri *, R. Sai Chandana, M. Sumakanth, R. Swethasri 1.RBVRRWomen’s College of Pharmacy Barkatpura, Hyderabad500027, India ABSTRACT The present work deals with the development of reliable method for the estimation of pioglitazone hydrochloride by using UV spectroscopy. The pioglitazone hydrochloride showed absorption maxima at wavelength 268nm respectively. The linearity range for pioglitazone hydrochloride was in the range of 10-50μg/ml with correlation coefficient of 0.999. The precision was carried out for pioglitazone hydrochloride and value was found to be less than 2. The proposed method’s results were found satisfactory and are suitable for determination of pioglitazone hydrochloride for routine quality control of drug in bulk and formulation. This method is validated according to ICH guidelines Q2R1.
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