Development and method validation for quantitative estimation of various drugs by different analytical techniques in bulk and pharmaceutical dosage forms and their stability studies

Abstract

Method development of active pharmaceutical ingredients and its validation according to ICH norms is an excellent research area, in the field of pharmaceutical analysis. The chromatography modus are very popular in laboratories as well in industries. Most widely used techniques are HPLC and LC-MS/MS which are giving precise results, with lowest concentration, in quantification of drug moieties in bulk and formulations. The main aim of this selected research activity is based on the requirement of industry in developing best fit analytical methods. Apart from the all other ancient analytical modus, the author focused on new sophisticated and modern techniques like HPLC, LC-MS/MS. HPLC has proven as a predominant technique widely used in laboratories and industry worldwide. Now a day s bioanalytical and bioequivalence studies are more popular in industry. The assay methods are very sensitive in estimation of biological samples even in Pico gram levels and producing data is most reliable and free from interference of endo and exogenous matter in biological sample. In HPLC the author performed a validation parameters like precision, accuracy recovery, linearity, robustness, ruggedness, and stability studies include oxidation, acid, base hydrolysis, thermal and photolytic reactions. In bioanalytical methods carry over test, sensitivity, selectivity, precision and accuracy batches, ruggedness, linearity, recovery, matrix effect, dilution integrity and stability studies including stock solution, bench top, auto sampler, free thaw, wet, dry extracts, short term long term stability etc.