Submitted To : Dr. Kevin Devine
Student Name : Srichakra Kumar Boddula
Student ID : 10035600
Module Title : Research Project M. Sc. Pharmaceutical Science
Abstract:
Kaletra (Lopinavir & Ritonavir combination) is a Human immuno deficiency virus (HIV) protease inhibitor had markedly reduced the mortality in patients suffering from HIV disease. It inhibits the gag-pol polyprotein cleavage by acting on HIV protease enzyme necessary for viral maturation (Yekkala et al, 2008). The aim of this study was to determine the stability of Ritonavir and Lopinavir under force degradation conditions such as hydrolysis (acidic-HCl, basic-NaOH, neutral-H2O / pH-7.4), oxidation (H2O2), reduction (NaHSO3) at 800C; against humidity & photolysis (sunlight) at room temperature using HPLC-UV method and characterisation of the degraded products using positive Electrospray ionisation-Mass spectrometry (+ve ESI-MS). The chromatographic conditions used were mobile phase’s methanol, acetonitrile, deionise water (20:44:36; v/v/v/) HPLC column Luna 5µ Phenyl-Hexyl column with UV detection at 210nm, injection volume 10µl with flow rate of 0.8ml/min at 400C (isocratically). RTV showed significant degradation against acidic, basic & neutral hydrolysis, oxidation, and reduction while LPV degraded under acidic, basic & neutral hydrolysis, oxidation. The method was validated for linearity, accuracy, and precision. The method was linear over a range of 1.56-100 µg/ml with the correlation coefficients (r2) = 0.9989 and r2 = 0.9993 for RTV & LPV respectively. The mean percentage recoveries were 129.099 with average %RSD of 0.99 and 143.01 with average %RSD of 0.87 for RTV & LPV correspondingly. LOD and LOQ for RTV were found to be 1.000 µg/ml and 3.032 µg/ml respectively. LOD and LOQ for LPV were found to be 1.549 µg/ml and 4.695 µg/ml correspondingly. The developed stability indicating method was significantly validated on pure RTV & LPV drugs.
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