Comparative Study of Glycemic Control and Adverse Effect Profile of Metformin and Vildagliptin vs Metformin and Glimepiride in Patients of Type -2 Diabetes Mellitus with Poor Glycemic Controlby Harinika.G, Sankar Kurli, Savithri Desai, India.

摘要

A simple, rapid, specific and highly sensitive stability indicating RP-HPLC method with PDA detection was developed for the estimation of Cilnidipine from bulk and its tablet dosage form. Efficient chromatographic separation was achieved on Kromasil C18 column (250mm X 4.6mm, 5μm) using isocratic elution and 240nm as a detection wavelength. The optimized mobile phase consists of methanol, sodium di-hydrogen ortho phosphate buffer (PH=3) and acetonitrile [75:18:7] with a flow rate of 1 mL/min. The reliability and analytical performance of the proposed HPLC method were validated for limit of detection, limit of quantification, linearity, range, precision, accuracy, specificity and system suitability. The developed method is linear in the range of 5-15 μg/mL with correlation coefficient being 0.9996. The relative standard deviation for intra and inter day precision were below 1.2%. Forced degradation of the drug was carried out under acidic, basic, oxidative, photolytic and thermal conditions and with the help of developed method the drug was successfully resolved from all degradation products.