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Method Development and Validation for the Simultaneous Estimation of Ertugliflozin and Sitagliptin in Bulk and Tablet Dosage Form by using HPLC.
Abstract
A simple, Accurate, precise method was developed for the simultaneous estimation of the Ertugliflozin and Sitagliptin in bulk and tablet dosage form. Chromatogram was run through DIKMA Spursil C18 column (4.6 mm x 150mm, 3.0 µm). Mobile phase containing KH2PO4: Methanol (45: 55) was pumped through column at a flow rate of 1ml/min. Temperature was maintained at Ambient. Optimized wavelength for Ertugliflozin and Sitagliptin was 225 nm. Retention time of Ertugliflozin and Sitagliptin were found to be 2.04 min and 2.53 min. The % purity of Ertugliflozin and Sitagliptin was found to be 100.15% and 100.30 % respectively. The system suitability parameters for Ertugliflozin and Sitagliptin such as theoretical plates and tailing factor were found to be 3234.04, 3765.44, 1.13 and 1.33. The linearity study for Ertugliflozin and Sitagliptin correlation coefficient (r2) was found to be 0.999 and 0.999, % mean recovery was found to be 99.64% and 100.01%, %RSD for repeatability was 0.8 and 0.2, % RSD for intermediate precision was 0.8 and 0.2 respectively. The precision study was precise, robust and repeatable. LOD value was 2.91 and 2.96, and LOQ value was 10.04 and 10.09 respectively. 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 bulk and tablet dosage form.
Keywords
References
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