Abstract

DEVELOPMENT AND VALIDATION OF STABILITY INDICATING RP-HPLC ASSAY METHOD OF RALTEGRAVIR IN TABLET DOSAGE FORMS

V. Shirisha*1, B. Sairaju, Santhosh Illendula and Dr. K. Rajeswar Dutt

ABSTRACT

A Stability indicating RP-HPLC assay method has been developed to quantitate Raltegravir potassium in tablet dosage forms. The comprehensive forced stress testing has been carried out as per ICH guideline Q1A (R2). The drug was subjected to hydrolysis (acid, alkali and neutral degradation), humidity, oxidation and thermal decomposition. RP-HPLC method was developed to separate analyte from all other degradation peaks. A chromatographic condition involved inertsil ODS C18 (100mm × 4.6mm i.d 5μ particle size) and isocratic mobile phase system consisting of (A) 0.1% Ortho phosphoric acid and (B) Methanol (50:50% v/v). The flow rate was 1.5mL.min-1 with UV detection at 300nm, based on peak area. The method was successfully validated as per ICH guideline Q2 (R1) for the purpose of conducting studies of the analyte in quality control (QC) laboratory. The drug was subjected to different degradation conditions; it was found to be unstable in all degradation conditions. Peak purity of the drug was passing in all degradation conditions which demonstrated the specificity of assay method for their estimation in presence of degradation products. The developed HPLC method was validated for linearity, accuracy, precision and robustness.

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