“Analytical method development and validation of pharmaceutical products using HPLC”

Abstract

This study presents the development, optimization and validation of a simple HPLC method for the determination of different pharmaceutical products using HPLC. Method development was carried out by using different column specially C18 column. In first study HPLC method development and validation was carried out on Metformin. By changing mobile phase composition found Symmetrical peak. Different column was used to get satisfactory result. It is also found that among Octyl and octadecyl columns and Oyster BDS C18 column, oyster gives symmetric peaks with high theoretical plates and low tailing factor. Simple, fast, economical, accurate, precise and reproducible HPLC methods also were developed for the determination of COX 2 inhibitors. The methods were validated in terms of specificity, linearity, precision accuracy, and robustness. The proposed method’s results were found to be satisfactory and are suitable for determination of COX 2 inhibitors for routine quality control of drugs in bulk drug and formulation. A simple and reproducible method was developed for anticancer drugs (Capcitabine, Cladribine, Fludarabine, Gemcitabine, Methotrexate, Epirubicin, Carmustine, Dacarbazine, Docetaxel, Paclitaxel, Vinblastin, Imatinib Mesylate) by Reverse phase high performance liquid chromatography (RP-HPLC). The separation was performed by C18 column at different temperature for different methods, as mobile phase different buffer, acetonitrile, methanol and water were used at different flow rate. The detection was performed by PDA (Photodiode array detection) detector, photo diode array UV-Visible detector were used at different wavelength. LOD (Limit of Detection) and LOQ (limit of quantification) ranged from 0.011 μg /mL to 1.16 μg/ml and from 0.047 μg /mL to 1.413 μg/mL respectively. The method which is developed is also validated in complete compliance with the current regulatory guidelines by using well developed analytical method validation techniques and tools which comprises with the analytical method validation parameters like linearity, accuracy, method precision, specificity with forced degradation, system suitability, robustness, ruggedness etc. adopting the current method the linearity obtained is near to 0.999 and thus this shows that the method is capable to give a good detector response, the recovery calculated was within the range of 98% to 102% of the specification limits.