عنوان المقالة:Simultaneous analytical method development and validation of amlodipine besylate and hydrochlorthiazide using reverse phase HPLC method in pharmaceutical dosage form Simultaneous analytical method development and validation of amlodipine besylate and hydrochlorthiazide using reverse phase HPLC method in pharmaceutical dosage form
The aim of the present work is to develop a precise, accurate, simple and reliable, less time consuming, RP-HPLC method for the simultaneous estimation of Amlodipine besylate and Hydrochlorothiazide in pharmaceutical formulation. First of all, maximum absorbance was found to be at 245 nm and the peaks purity was excellent. Injection volume was selected to be 20 μl which gave a good peak area. The column used for study was Hypersil C18, BDS chosen good peak shape. Ambient temperature was found to be suitable for the nature of drug solution. The flow rate was fixed at 1.0 mL/min because of good peak area and satisfactory retention time. Different ratios of mobile phase were studied, mobile phase with ratio of 50:50 Water: Acetonitrile was fixed due to good symmetrical peaks and for good resolution. The present recovery was found to be 98.0-101.5 was linear and precise over the same range. Both system and method precision was found to be accurate and well within range. Detection limit was found to be 0.77 for Amlodipine and 0.35 for Hydrochlorthiazide. The analytical method was found linearity over the range of 20-80 ppm of the target concentration for both the drugs. The analytical passed both robustness and ruggedness tests. On both cases, relative standard deviation was well satisfactory.