Abstract

DEVELOPMENT AND VALIDATION OF STABILITY INDICATING RP-HPLC METHOD FOR SIMULTANEOUS ESTIMATION OF TENELIGLIPTIN AND PIOGLITAZONE IN PHARMACEUTICAL DOSAGE FORM

*Komal Vaishnav, Priyanka Yadav, and Vinita Talreja

ABSTRACT

A Specific, sensitive, accurate, precise and robust gradient RP-HPLC method was Developed and validated for Teneligliptin and Pioglitazone, using Zorbax c18 (250mm*4.6mm)5m column with flow rate 1.0ml/min and Detection Wavelength of 243 nm. The mobile phase is Buffer:ACN(50:50%v/v) and injection volume is 20μl.total run time 20 min. Detection carried out at 243nm wavelength. The stability indicating capability of method was established by forced degradation studies of bulk and Pharmaceutical dosage form. The developed method was validated as per International Conference Of Harmonization (ICH)for specificity, linearity, accuracy, precision, robustness, limit of detection, and limit of quantification. Stability Indicating Study suggested that major degradation of bulk was observed in Thermal condition and form was observed in Oxidative condition. Correlation co-efficient for calibration curve of teneligliptin and Pioglitazone was found to be 0.999. The RSD for precision and robustness was found less than 2.

Keywords: Teneligliptin, Pioglitazone, Stability Indicating, Method was validated.