Abstract
HPLC method development and validation plays an important role in the discovery, manufacturing, development of pharmaceutical products. HPLC methods are able to separate, detect and quantify various drugs their related substances, degraded products and impurities that may be introduced during the synthesis of drug substance. Here in this review various strategies for method development and validation on HPLC are well described. Along with this systematic approach for method validation is also described. Method validation establishes the performance characteristics and limitations of the developed method. Optimization of chromatographic conditions includes fixation of parameters like mobile phase, stationary phase, detection wavelength, elution mode that must affords to system suitability as well as stability of drugs, degradants, impurities. Force degradation studies helpful in the development and validation of stability indicating assay. They also demonstrates the specificity while developing stability indicating assay.
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