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

Rana Siddhi, Priyanka Patil, Aarti Yadav*, Chainesh Shah, Naina and Umesh Upadhyay

ABSTRACT

This work aimed to develop and validate a simple, accurate, precise, and reproducible spectroscopic method for simultaneous estimation of Rosuvastatin calcium and Gemigliptin tartrate by UV-Visible first-order derivative method. According to our present knowledge, no UV method was reported for combination of Rosuvastatin Calcium and Gemigliptin tartrate. So, in this work, it was decided to performed the first-order derivative method and it was validated as per ICH(Q2 R1) guideline. Rosuvastatin calcium and Gemigliptin tartrate showed absorbance at the working wavelength of 242nm (Zero crossing point of Rosuvastatin calcium) and 248nm (Zero crossing point of Gemigliptin tartrate) respectively, using methanol as diluent. The linearity of this method was found in the concentration range of 20 to 300 μg/ml for Gemigliptin Tartrate and Rosuvastatin Calcium. The correlation coefficient r value was found to be 0.9985 for Gemigliptin Tartrate and 0.998 for Rosuvastatin Calcium. The method was extensively validated according to ICH guidelines for Linearity, Range. Precision, specificity and Robustness.

Keywords: UV, Validation, Gemigliptin Tartrate, Rosuvastatin Calcium.


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