DEVELOPMENT AND VALIDATION OF STABILITY – INDICATING RP-HPLC CHROMATOGRAPHIC METHOD BY FORCED DEGRADATION STUDIES FOR AZATHIOPRINE BY RELATED SUBSTANCESAbstract
Simple, rapid and reproducible stability-indicating methods were established for quantitative determination of azathioprine using a, phenomenex 250 mm × 4.9 mm C18, 5 µm, inertsil and UV detection at 240 nm. The isocratic elution was used to quantify the analyte and the mobile phase was acetate buffer: acetonitrile: methanol (30: 35: 35) was pumped at 1.0 mL/min. The method was linear between 10-300 µg/mL, statistically validated for its linearity, precision and accuracy. In this study, degradation behavior of azathioprine was studied by subjecting the drug to various ICH stress conditions. The intra and inter day variation was found to be less than 1% showing high precision of the assay method. It was found that the excipients in the commercial tablet did not interfere with the method. Developed method can routinely use for the estimation of azathioprine related compounds from the dosage form and also for stability sample.
S. M. Hiralben *, I. Shinghvi and H. A. Raj
Pacific Academy of Higher Education and Research University, Airport Road, Pratap Nagar, Debari, Udaipur, Rajasthan, India.
16 February, 2018
02 May, 2018
13 May, 2018
01 November, 2018