ROBUST SIMPLE ANALYTICAL TECHNIQUE FOR DEVELOPMENT AND VALIDATION OF STABILITY INDICATING ASSAY METHOD FOR ESTIMATION OF TENELIGLIPTIN IN PHARMACEUTICAL DOSAGE FORM

As per the ICH guidelines and regulatory authorities’ worldwide, it has become mandatory to establish a stability-indicating assay method (SIAM) for the drug substance (DS) and drug product (DP) to generate the stability data. It was undertaken to develop a precise, accurate, reliable, rapid, simple and specific method for estimating Teneligliptin free of interference from its probable degradation products. The present investigation has exploited the high-performance liquid chromatography (HPLC) technique. The retention time of Teneligliptin under optimized chromatographic conditions was found to be 5.71 ±0.02 min with a sharp, symmetrical peak (asymmetry of 0.66 ± 0.02). In the system suitability, the drug was found to adequately retain at 5.71 ±0.02 min with a sharp, symmetrical peak and high theoretical plate value of 4808, indicating high column efficiency. The solutions were observed to undergo hydrolysis in 0.1 N HCl and 0.1 N NaOH at room temperature and reflux. Teneligliptin was also found to be susceptible to rapid oxidation. Photolytic stress study indicates that drug in solid-state upon exposure to sunlight for 12 days up to 48%. Thermal stress conditions do not degrade the drug upon exposure to 100 ˚C for 15 days. This indicates that Teneligliptin is quite stable in thermal stress conditions. The standard and sample solutions of the drug have reasonably good stability over a period of about 24 h. The results of the assay of the Tenglyn tablet obtained by the proposed HPLC method are quite concurrent and reproducible. The recovery rate of the drug was 100% which indicates accuracy and reproducibility.