Development and Validation of Stability Indicating Method for the Simultaneous Estimation of Batcaver Sulfate, Lamivudine and Dolutegravir Sodium in Pharmaceutical Dosage forms by RP-HPLC
Journal Title: Saudi Journal of Medical and Pharmaceutical Sciences - Year 2018, Vol 4, Issue 2
Abstract
Abstract:A simple, rapid, specific, stability indicating method was developed and validated for the simultaneous estimation of Abacavir sulfate, Lamivudine and Dolutegravir sodium in pharmaceutical dosage form using RP-HPLC. The chromatographic separation was done using BDS column of dimensions 250mm x 4.6mm, 5m particle size with mobile phase consisting of potassium dihydrogen phosphate buffer and acetonitrile in the ratio 45:55%v/v run on an isocratic mode of flow rate 1.0ml/min. The column oven temperature was maintained at 30ºC. The detection was done at a wavelength of 240nm. The developed method was validated in accordance with ICH guidelines, evaluating accuracy, precision, ruggedness, robustness, LOD, LOQ, stability parameters and found to be within the limits. The method obeys Beer’s law in the concentration range of 150mg/ml – 900mg/ml for Abacavir, 75mg/ml – 450mg/ml for Lamivudine and 12.5mg/ml – 75mg/ml for Dolutegravir with correlation coefficients of 0.9999, 0.9996 and 0.9999 for the three drugs respectively. Forced degradation studies were conducted by exposing the standard drug solution to the various stressed conditions such as acidic, basic, oxidative, thermal, neutral and photolytic conditions. The net degradation for the drugs was found to be within the limits. Keywords:Abacavir sulfate, Lamivudine, Dolutegravir sodium, RP-HPLC, Stability indicating method, Method development, Validation.
Authors and Affiliations
Gorja Ashok, Sumanta Mondal
Keywords
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