RP-HPLC is the most powerful and dominant analytical technique available in todays world of pharmaceutical analysis. This review presented a step-by-step approach to RP-HPLC method development and its validation. Method development, validation and its life cycle management must incorporate in it the concept of QbD and QRM. Exhaustive chromatographic literature review and collecting maximum information on sample is very first prerequisite of method development. It further requires performing various experiments with sound judgement on selection of chromatographic conditions like mobile phase, stationary phase, column temperature, flow rate, detector and detection wavelength, injection volume, etc for method optimization. Further to fasten and simplify the development work latest automated method scouting techniques can be used. Gradient scouting is a powerful technique to screen between isocratic or gradient method. Validation of analytical procedure requires addressing various validation characteristics like accuracy, precision, specificity, linearity, range, LOD, LOQ, robustness. Statistical analysis of validation data shall be used to evaluate validation characteristics against predetermined acceptance criteria. Once the validation is successful the analytical method could be transferred to laboratories for routine application.
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