A NEW DEVELOPMENT AND VALIDATION OF STABILITY INDICATING RP-HPLC METHOD FOR THE DETERMINATION OF ANTI-RETROVIRAL DRUGS IN PHARMA-CEUTICAL DOSAGE FORMAbstract
In this study, a new simple, rapid and accurate, sensitive isocratic method was developed for the simultaneous determination of the Anti-retroviral drugs in pharmaceutical dosage forms. The chromatography was run through Denali C18 column (150 x 4.6 mm and 5 µm particle size). Mobile phase containing mixer of buffer 0.1% OPA (PH.4.6) acetonitrile is taken in the ratio 40:60 was pumped through column at a flow rate of 0.8ml/min and isocratic elution with a total runtime of 7 minutes. The mixer of the buffer used in this method was 0.1% OPA. The temperature was maintained at 20 °C to 30 °C, optimised wavelength selected was 258 nm. The retention time of the lamivudine and Efavirenz were found to be 2.131 min and 3.058 min as respectively. The drug was stressed under alkaline (acid, base); oxidative, thermal, photolytic degradation was analysed. The validated method was developed as per ICH Guidelines. The accuracy, linearity, precision, robustness, LOD and LOQ was within the acceptable limits. Hence, this RP-HPLC method was stability-indicating can be used for routine stability analysis of the Lamivudine and Efavirenz in pharmaceutical dosage forms.
Badikela Ramakrishna * and Sumanta Mondal
Department of Pharmaceutical Analysis & QA, Guru Nanak Institutions Technical Campus-School of Pharmacy, Ibrahimpatnam, Ranga Reddy, Telangana, India.
22 November 2020
24 July 2021
11 October 2021
01 November 2021