“Development of an analytical method at the level of its validation employing liquid phase chromatography using HPLC”
Abstract
HPLC method development and validation plays an important role in the discovery, manufacturing, and 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. 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 are helpful in the development and validation of stability indicating assay. They also demonstrate the specificity while developing stability indicating assay.
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References
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