Simultaneous Estimation of Repaglinide and Voglibose in Newly Approved Fixed-Dose Combination by using UFLC: Application to ICH Q14 Concept and Comparative Method Greenness Assessment

A validated liquid chromatographic method was developed to estimate repaglinide and voglibose present in a newly approved fixed dose combination. Critical method variables such as organic proportion, pH and flow of the mobile phase were identified. The identified variables were investigated using chemometrics and effect on analyte retention and resolution was studied. The optimized chromatographic condition utilized acetonitrile: 0.01 M KH2PO4 buffer pH 3.4 (using orthophosphoric acid) (79:21%, v/v) flowing at a flow rate of 1.2 mL/min. Diode array detection was carried out at 244 nm.The new analytical method was validated as per ICH regulations and found to be linear, accurate, precise and sensitive. Both drugs were recovered to the optimum (> 99%) level. Further, method greenness was compared by using multiple tools. This developed method based on ICH Q14 concept is scientifically sound and can be applied for quality control of both the anti-diabetic drugs in their combined formulation.