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NEW SENSITIVE UV SPECTROPHOTOMETRIC METHODS FOR SIMULTANEOUS ESTIMATION OF ZIDOVUDINE AND LAMIVUDINE IN FIXED DOSE COMBINATION

机译:用于同时估计固定剂量组合的齐凡德和拉米夫定的新敏感紫外分光光度法

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摘要

Two new, simple, accurate and sensitive UV spectrophotometric methods have been developed and subsequently validated for the simultaneous estimation of zidovudine and lamivudine in a fixed dose combination. Zidovudine and lamivudine have an absorption maxima at 267.3 nm and 272.3 nm respectively. The first method is based upon the simultaneous equation and second upon the determination of Q value. The simultaneous estimation method is based upon the measurements of ratios of absorptivity and absorbance, of both the components at their absorption maxima. The method of Q analysis is based on the measurement of ratios of absorptivity and absorbance, of both components at two selected wavelengths; one is an isoabsorptive point i.e. 270.1 nm and other being the wave length maxima of any of the two components, say lambd,maxof zidovudine i.e. 267.3 nm. Both zidovudine and lamivudine shows linearity over the concentration range of 4-12 ppm at their respective absorption maxima and at isoabsorptive point. The assay and recovery studies from fixed dose combination as tablet dosage form are indicative of accuracy of the proposed methods. The developed methods were validated in accordance to International Conference on Harmonization (ICH) guidelines for linearity, range, accuracy and precision.
机译:已经开发了两种新的,简单,准确和敏感的紫外分光光度法,并随后验证了在固定剂量组合中同时估计Zidovudine和Lamivudine的同时估计。齐维丁和拉米夫定分别在267.3nm和272.3nm处具有吸收最大值。第一种方法基于同时等式和第二在确定Q值时。同时估计方法基于吸收率和吸收比率的比例的测量,这些组分在其吸收最大值中的组分。 Q分析方法基于两个选定波长的两个组件的吸收率和吸光度比率的测量;一个是IsoaBsorptive Point I.E.270.1 NM和其他是两个组件中任一方面的波长最大值,例如Lambd,Maxof Zidovudine I.E.267.3 NM。齐凡押和拉米夫定都显示出在其各自的吸收最大值和异构点的4-12ppm浓度范围内的线性度。作为片剂剂型的固定剂量组合的测定和恢复研究表明了所提出的方法的精度。开发的方法是根据国际协调会议(ICH)线性,范围,准确性和精度指南的国际会议进行验证。

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