Abstract

DEVELOPMENT AND VALIDATION OF RP–HPLC METHOD FOR ESTIMATION OF DAPAGLIFLOZIN PROPANEDIOL MONOHYDRATE AND TENELIGLIPTIN HYDROBROMIDE HYDRATE IN PHARMACEUTICAL DOSAGE FORMS

*Nandish M. B., Dr. S. Vijaya Bhaskar, Manjunath M. G., Yamuna J.,

Abstract

A straightforward, precise, and validated Reverse Phase-High Performance Liquid Chromatographic (RP-HPLC) method was established for the determination of Dapagliflozin propanediol monohydrate (DAPA) and Teneligliptin hydrobromide hydrate (TENA) in tablet formulation Separation was performed using a Shimadzu Shim-pack C8 column (4.6 × 250 mm, 5 μm) with a mobile phase comprising HPLC-grade acetonitrile and Phosphate buffer (60:40 %v/v), adjusted to pH 4 with 1% ophosphoric acid, at a flow rate of 1.0 ml/min. Detection was carried out at 220 nm for both analytes, yielding retention times of 3.9 min for DAPA and 2.9 min for TENA. The method demonstrated excellent linearity over the concentration ranges of 5-25 μg/ml for DAPA and 10-50 μg/ml for TENA, with correlation coefficients of 0.9992 and 0.9994 respectively. Limits of detection and quatification were found to be 0.49766 μg/ml and 1.50806 μg/ml for DAPA, and 0.66921 and 2.02791 μg/ml for TENA respectively. Validation parameters including accuracy, precision, and robustness complied with ICH Q2 (R2) guidelines, confirming the method’s suitability for routine quality control of combined pharmaceutical dosage forms.

Keywords: DAPA, TENA, Validation, RP-HPLC, Accuracy and precision, Repeatability.