DEVELOPMENT AND VALIDATION OF FIRST ORDER DERIVATIVE SPECTROPHOTOMETRIC METHOD FOR SIMULTANEOUS ESTIMATION OF ROSUVASTATIN CALCIUM AND GEMIGLIPTIN IN SYNTHETIC MIXTURE

J Binal, Parekh
2018 J. Global Trends Pharm Sci   unpublished
Key words Rosuvastatin calcium, Gemigliptin, U.V Spectrophotometer, First order derivative, Synthetic Mixture, Validation method. A simple, precise and accurate UV-Spectrophotometric Method for simultaneous estimation of Rosuvastatin calcium and Gemigliptin in Synthetic Mixture. In The first order derivative method absorption at 223 (zero crossing point for Rosuvastatin calcium) was used for Gemigliptin and 253 nm (zero crossing point for Gemigliptin) was used for Rosuvastatin calcium. The
more » ... n calcium. The linearity was taken in the concentration range of 4-24 µg/ml for Rosuvastatin calcium and 10-60 µg/ml for Gemigliptin with correlation coefficient (R 2) 0.998 and 0.997, respectively. The developed method was validated according to ICH (Q2 R1) guidelines and whereby %RSD values were found to be ≤2% complying the validation requirements. Method can be applied to the simultaneous estimation of Rosuvastatin calcium and Gemigliptin in their Synthetic Mixture. The results of analysis have been validated statistically and by recovery studies.
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