Abstract
ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS ESTIMATION OF ERTUGLIFLOZIN AND SITAGLIPTIN IN PHARMACEUTICAL DOSAGE FORM BY RP-HPLC

Ch. Rani and M. Pravalika*

ABSTRACT

Objective: A New method was established for simultaneous estimation of Ertugliflozin and sitagliptin by RP-HPLC method. Methods: Chromatogram was run through Inertsil ODS C185m (4.6 x 250mm). Mobile phase containing Phosphate buffer and Acetonitril in the ratio of 30:70 was pumped through column at a flow rate of 1ml/min. Buffer used at pH 4.6. Temperature was maintained at Ambient. Optimized wavelength for Sitagliptin and Ertugliflozin was 235 nm. Results: Retention time of Sitagliptin and Ertugliflozin were found to be 2.395min and 3.906min. The % purity of Sitagliptin and Ertugliflozin was found to be 100.6% and 101.3% respectively. The system suitability parameters for Sitagliptin and Ertugliflozin such as theoretical plates and tailing factor were found to be 1.3, 1012.4and 1.2, 1848.2 the resolution was found to be 9.0.The linearity study for Sitagliptin and Ertugliflozin was found in concentration range of 1μg-5μg and 100μg-500μg and correlation coefficient (r2) was found to be 0.999 and 0.999, % mean recovery was found to be 100.1% and 100.4%, %RSD for repeatability was0.31 and 0.38, % RSD for intermediate precision was 0.12 and 0.15 respectively. The precision study was precise, robust and repeatable. LOD value was 2.94 and 3.03, and LOQ value was 9.87 and 10.1 respectively. Conclusion: The results of study showed that the proposed RP‐HPLC method is a simple, accurate, precise, rugged, robust, fast and reproducible, which may be useful for the routine estimation of Ertugliflozin and sitagliptin in pharmaceutical dosage form.

Keywords: Ertugliflozin, sitagliptin, RP?HPLC, Simultaneous estimation.


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