DEVELOPMENT OF A NEW STABILITY INDICATING RP-HPLC METHOD FOR SIMULTANEOUS ESTIMATION OF METFORMIN HYDROCHLORIDE AND TENELIGLIPTIN HYDROBROMIDE AND ITS VALIDATION AS PER ICH GUIDELINES

A new stability indicating RP HPLC method has been developed and validated for simultaneous estimation of Metformin Hydrochloride and Teneligliptin in bulk and dosage forms. The method involves separation on YMC C18column(150mm x 4.6mm x5µm particle size). The optimized mobile phase consists of Phosphate buffer (pH 3) and Acetonitrile (80:20v/v) with a flow rate of 0.8ml/min and UV detection at 220mn. Retention time was 2.138min (Metformin Hydrochloride), 2.943min (Teneligliptin), 5.075 Pioglitazone. Linearity range was 9.98-600ug/ml (Metformin Hydrochloride), 0.51-24ug/ml (Teneligliptin). Accuracy was in the range of 99.41-100.74% for both drugs. Precision was 0.8% and 0.9% for Metformin Hydrochloride and Teneligliptin. LOD and LOQ are 0.72ug/ml and 2.40ug/ml for Metformin Hydrochloride, 0.15ug/ml and 0.51ug/ml for Teneligliptin. The method developed is sensitive, accurate and precise. Retention time and run time were also less and hence the method is economical. When applied for tablet assay, drug content was within 99.89-100.74 % of labeled content. Forced degradation studies indicated the suitability of the method for stability studies. Key words: Metformin Hydrochloride, Teneligliptin, RP-HPLC Method, Simultaneous estimation, Validation as per ICH guidelines, Forced degradation studies.