Abstract

DEVELOPMENT AND VALIDATION OF STABILITY INDICATING RPHPLC METHOD FOR SIMULTANEOUS ESTIMATION OF TENELIGLIPTIN HBR HYDRATE, METFORMIN HCL AND PIOGLITAZONE HCL IN TABLET DOSAGE FORM

Mayuri M. Prajapati*

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Abstract

A simple, specific, precise, accurate and robust stability indicating RPHPLC method has been developed and subsequently validated for the separation and quantification of Teneligliptin Hydrobromide Hydrate, Metformin Hydrochloride and pioglitazone Hydrochloride in tablete dosage form. The quantification was carried out using Zodiac C18 (250 nm x 4.6 mm, 5μm) as stationery phase and mobile phase composition Acetonitrile: Methanol: Buffer pH 3 adjusted with 10% GAA in proportion of 25:25:50 v/v. The flow rate was adjusted to 1 ml/min and the iffluent was monitored at 225 nm using PDA detector. The retention time of Teneligliptin was 2.992 min, Metformin was 2.186 min and Pioglitazone was 11.483 min. The describe method was linear over a concentration range of 10-30 μg/ml for teneligliptin, 25-75 μg/ml for metformin and 7.5-22.5 μg/ml for pioglitazone. The percentage recovery of Tneligliptin was found to be 98.90% - 99.53%, Metformin was found to be 98.85% - 99.51% and Pioglitazone found to be 99.29% - 99.64%. Method was statistically validated for accuracy, precision, specificity, LOD, LOQ and robustness according to ICH guidelines. Forced degradation study was carried out under various stress conditions. The drug degraded in Acid, Base, Oxidative and Thermal conditions. All results was found satisfactory so, the stability indicating assay method can be applied to the tablet dosage form.

Keywords: Teneligliptin Hydrobromide Hydrate, Metformin Hydrochloride, Pioglitazone Hydrochloride, RP-HPLC, Stability Indicating, Method Validation.