Development and validation of analytical methods for some anti viral drugs in dosage forms using novel approaches

Abstract

The present work represents UV spectrophotometric method, Chemometrics assisted UV spectrophotometric method, RP-HPLC, Stability indicating RP-HPLC method for the determination of anti-viral drugs in single and in combined dosage form. The Difference spectroscopic method was developed for the estimation of Daclatasvir Dihydrochloride in dosage form. The simultaneous estimation of Sofosbuvir and Daclatasvir Dihydrochloride in dosage form was accomplished by the application of Dual wavelength method, Ratio derivative method, Chemometrics (CLS, ILS, PCR and PLS) assisted UV spectroscopic methods. UV spectrophotometric methods like Simultaneous equation method, Q - absorbance ratio method, Dual Wavelength method, First Derivative Method, Ratio Derivative Method were developed for the simultaneous determination of Lamivudine and Dolutegravir Sodium in dosage form. The RP-HPLC method was developed for the simultaneous determination of Lamivudine and Dolutegravir Sodium in dosage form. Chemometrics assisted (CLS, ILS, PCR and PLS) spectrophotometric methods and Ratio Derivative (Double Divisor) Method have been developed for simultaneous estimation of Abacavir Sulphate, Lamivudine and Dolutegravir Sodium in the dosage form. The Stability Indicating RP-HPLC method and Chemometrics assisted UV spectrophotometric method were developed for the simultaneous estimation of Emtricitabine, Tenofovir Alafenamide Fumarate and Dolutegravir Sodium in dosage form. The degradation study was carried out under different environments like acidic, alkaline, neutral, oxidative, photolytic and thermal conditions. All the developed methods were validated in terms of linearity, accuracy, precision, robustness, limit of detection, limit of quantitation, repeatability and system suitability as per ICH Q2 (R1) guideline. The developed methods were statistically compared using one way ANOVA. newlineThe calibration curve of all the developed methods were found linear over the proposed concentration range. Percentage assay values and Percent recoveries of