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A Stability Indicating Assay Method For Candesertan Tablets By High Performance Liquid Chromatography For Stability Studies

Monika Jain, S.N.Shrivastava

A simple and stability indicating HPLC assay procedure had been developed and validated for candesertan tablets. The mobile phase consisted of buffer(6.8g KH2PO4 /1000ml water): methanol : in the ratio of (40:60) isocratic elution is carried out under ambient condition at flow rate of 1.0ml min-1 and detector was set at 220nm. The column selected was thermohypersil, C18, 5μm packing, 4.6mm×250mm and injection volume was 20μl. The procedure separated candesertan and potential degradation product. The retention time of candesertan is 11.3 min and asymmetry was 1.17. The instrument precision obtained was 0.18 %.The procedure provided a linear response in the range of 50-150% of target concentration(r=1.000). Forced degradation study shows, response of main drug is reduced in acid, alkali, peroxide thermal and sunlight degradation. The method was validated for accuracy, robustness and solution stability was obtained up to 14 hrs.