Analytical Method Development and Validation studies of Drug Abacavir. RP HPLC studies on Abacavir Sulphate

      Аннотация: Quality assurance is the branch of analytical chemistry which involves the methods and practices applied to ensure reliable laboratory outcomes. Analytical method development and Validation helps in systematic quantification of drug candidate in vitro and in vivo. Validation indicates whether the analytical purpose of the method is achieved with acceptable limits. Method Development includes Selection of column, wavelength, mobile phase, empirical analysis, drug solubility, trials and Optimization of result. Validation studies comprise Specificity, Linearity, Range, Precision, Repeatability, Reproducibility, Accuracy, Limit of Detection, Limit of Quantification, Ruggedness and Robustness. This book gives insights of RPHPLC method development and validation studies of Abacavir sulphate.

Ключевые слова: Abacavir sulphate, RP-HPLC, method development, validation