Abstract

A VALIDATED RP-HPLC METHOD FOR SIMULTANEOUS ESTIMATION OF TENELIGLIPTIN AND PIOGLITAZONE IN PHARMACEUTICAL APPLICATIONS

V. Mounika*, Ravi Babu K., Nagaraju Pappula and G. Indira Priyadarshini

Abstract

A validated RP-HPLC method was developed and validated for the simultaneous estimation of TEN and PIO. HPLC method was developed in reverse phase mode using Acetonitrile, methanol and ammonium acetate buffer (pH 4.7 adjusted with orthophosphoric acid) as mobile phase in the ratio of 40:20:40 (v/v/v) over Inertsil BDS column (250×4.6mm, 5μm) at a volumetric rate 1mL/min and Quantitation was achieved with PDA detector at 247nm and elution time was identified to be 3.539 min and 6.075 min for TEN and PIO respectively. According to ICH guidelines the developed method was validated. The linearity was considered to be in the range of 10-30 μg/mL and 5 – 25 μg/mL with correlation coefficient of 0.999 and 0.999 for TEN and PIO respectively. The developed method is validated and the peaks were more resolved when compared to the previous literatures with reduced run time. The % RSD of TEN and PIO were 0.93 and 1.16. The regression coefficient of TEN and PIO were Y=19208X+3366and Y=6001X+225.1 respectively. The mean recovery was considered to be 99.73 and 99.88% of TEN and PIO respectively. Method was precise and robust with a % RSD NMT 2. Hence the developed RP-HPLC method was assessed to be specific and can be used for conventional analysis and academics also this expedite as an analogous method for synchronous estimation of drugs TEN and PIO in marketed formulation since there was no co-elution of peak with the drug.

Keywords: Anti-diabetic, TEN, PIO, RP-HPLC, ICH.