Stability indicating method development and validation for the simultaneous estimation of Cyclosporin and Danazole by using RP HPLC in bulk and pharmaceutical dosage forms
Journal Title: Indian Journal of Research in Pharmacy and Biotechnology - Year 2017, Vol 5, Issue 4
Abstract
A simple and selective LC method is described for the determination of Cyclosporine and Danazole in tablet dosage forms. Chromatographic separation was achieved on a c18 column using mobile phase consisting of a mixture of 55 volumes of water and 45 volumes of Methanol with detection of 295 nm. Linearity was observed in the range 40-140 µg/ml for Cyclosporine (r2=0.988) and 40-140 µg /ml for Danazole (r2 =0.992) for the amount of drugs estimated by the proposed methods was in good agreement with the label claim. The proposed methods were validated. The accuracy of the methods was assessed by recovery studies at three different levels. Recovery experiments indicated the absence of interference from commonly encountered pharmaceutical additives. The method was found to be precise as indicated by the repeatability analysis, showing %RSD less than 2. All statistical data proves validity of the methods and can be used for routine analysis of pharmaceutical dosage form.
Authors and Affiliations
Anusha Malladi, M. Aseervadamma
Keywords
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- EP ID EP33466
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