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Simultaneous Spectrophotometric Estimation of Emtricitabine and Tenofovir disoproxil fumarate by Area Under Curve Method in Combined Dosage Form Rele Rajan V.1,* 1Central Research LaboratoryD.G. Ruparel College, Matunga, Mumbai400016. *Corresponding Author E-mail:drvinraj@gmail.com
Abstract The objective of the study was to develop a simple, accurate, precise and rapid a UV spectrophotometric method, area under curve method for the determination of emtricitabine and tenofovir disoproxil fumarate in combined dosage form. The method was further validated by ICH guidelines. The proposed area under curve method involves the measurement of area at selected analytical wavelength ranges and performing the analysis using “Cramer’s rule and Matrix method”. The two analytical wavelengths ranges were used i.e. 255-265nm and 272286nm for estimation of emtricitabine and tenofovir disoproxil fumarate respectively. The linearity of the proposed method was found in the concentration range of 2 - 20μg/ml (r2= 0.9999) for emtricitabine and tenofovir disoproxil fumarate respectively. The percentage mean recovery was found to be 100.129% emtricitabine and 100.30% for tenofovir disoproxil fumarate respectively. The method was statistically validated for its linearity, accuracy and precision as per ICH guidelines. Both intra and inter day variation showed less percentage (%) RSD values indicating high grade of precision of this method. Top Keywords UV spectrophotometric estimation, Emtricitabine, Tenofovir disoproxil fumarate, Validation. Top | | | |
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