Development and validation of a stability indicating HPLC method for analysis of Altretamine in bulk drug and pharmaceutical formulations
Journal Title: Indian Journal of Research in Pharmacy and Biotechnology - Year 2013, Vol 1, Issue 6
Abstract
A simple, sensitive and accurate stability indicating HPLC method has been developed and validated for determination of Altretamine in its bulk form and pharmaceutical formulations. Chromatographic separation was achieved on a Hypersil BDS C18 column (100 mm x 4.6 mm I.D., particle size 5 µm) by a mobile phase consisted of phosphate buffer and acetonitrile (90:10, v/v) with apparent pH of 3.1±0.5 and a flow rate of 1.0 mL/min. The detection wave length was set at 227 nm. An excellent linearity was observed for Altretamine in the concentration range of 25-150 µg/mL with a correlation coefficient of 0.999. The retention time was 2.533 min. The percentage assay of Altretamine was 99.98%. The method developed was validated for accuracy, precision, linearity, ruggedness, robustness, solution stability, selectivity and forced degradation studies like acidic, alkaline, oxidative, thermal, hydrolytic and photolytic stress conditions were performed as per ICH guidelines. The results demonstrated that the method would have a great value when applied in quality control and stability studies of Altretamine.
Authors and Affiliations
M. Karimulla Santhosh, A. Sreedevi, L. Kalyani, A. Lakshmana Rao
Keywords
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