Development and Validation of RP-HPLC Method for Simultaneous Estimation of Metformin Hydrochloride and Sitagliptin Phosphate from Bulk and Combined Dosage Form

Author(s)

Shirode, A. R., Deodhar, M. S., Maduskar, P. D., Kadam, V. J.

Author's Affiliation

Abstract

A simple, accurate, precise and rapid reversed-phase high performance liquid chromatographic (RP-HPLC) method has been developed and subsequently validated for the simultaneous estimation of Metformin Hydrochloride and Sitagliptin Phosphate in pure and tablet formulation. The proposed method is based on the separation of the two drugs in reversed-phase mode using BDS HYPERSIL C18 (4.6mmø×250mm) analytical column. The optimised mobile phase consisted of phosphate buffer (pH adjusted to 4 using o-phosphoric acid): Methanol: Acetonitrile in the ratio of 50:30:20 v/v/v. Flow rate was kept at 0.8 ml/min. The simultaneous estimation was carried out at detection wavelength of 253 nm using variable wavelength detector. Both drugs- Metformin Hydrochloride and Sitagliptin Phosphate were well resolved and retained at 3.15 minutes and 6.05 minutes respectively. The method was statistically validated as per ICH guideline for analytical method validation. The validated method was used for simultaneous estimation of Metformin Hydrochloride and Sitagliptin Phosphate from their marketed tablet formulation.

Keywords

RP-HPLC, Sitagliptin Phosphate, Metformin Hydrochloride, Tablet Formulation, Validation

Cite This Article

Shirode, A. R., Deodhar, M. S., Maduskar, P. D., & Kadam, V. J. (2014). Development and Validation of RP-HPLC Method for Simultaneous Estimation of Metformin Hydrochloride and Sitagliptin Phosphate from Bulk and Combined Dosage Form. International Journal for Pharmaceutical Research Scholars (IJPRS), 3(2), 681-689.