Development and Validation of RP-HPLC Method for Estimation Ertugliflozin in Its Bulk and Tablet Dosage Form

Jayesh Ahirrao; R. S. Bachhav

Abstract

Background: This study developed and validated a new, sensitive, appropriate, clear, accurate, and robust reversed-phase high-performance liquid chromatography (RP-HPLC) method for determining safinamide in bulk medication and tablet formulations. An HPLC procedure using a UV detector and the Openlab EZchrome workstation programme was used to separate the samples, as well as a Kromasil C18 (250 mm × 4.6 mm i.d.) 5 μm. At a flow rate of 1.0 mL/min, methanol and buffer (70:30 percent v/v) were pumped and detected at 223 nm. Result: The new RP-HPLC method gave a satisfactory retention time of 7.95 min for ertugliflozin, which was optimised by trial and error. A correlation coefficient was used to verify the linearity of the established approach (r2) of 0.99995 over the concentration range of 2.00–30.00 ug/mL. The percentage RSD for the method's precision was found to be less than 2.0 percent. The percentage recoveries were discovered to be between 98.56 and 100.90%. 0.37 ug/mL and 1.12 ug/mL The LOD and LOQ, respectively, were discovered. Conclusion: The newly built and validated RP-HPLC technology saves time and effort can be used in the industry for routine quality control/analysis of bulk drug and marketed ertugliflozin products.

Abstract

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