Review Article of Dissolution Test Method Development and Validation of Dosage Form by Using RP-HPLC

Dissolution is precise test method used for evaluating drug release of solid and semisolid dosage forms. It is the process by which a solid solute enters a solution. For the analysis of dissolution test method development, the Reverse Phase High Performance Liquid Chromatography is used, and it is the modern of column chromatography. In the reverse phase partition HPLC the relative polarity of the stationary and mobile phase opposite to those in normal HPLC. The main applications of the dissolution testing include biopharmaceutical characterization of the drug product, as a tool to make sure consistent product quality and to predict in vivo drug bioavailability. The article represents the current updates in dissolution testing methods by using Reverse Phase High Performance Liquid Chromatography. The validation parameters explain for the analysis of sample is accuracy, precision, repeatability, detection of limit, quantitative limit, linearity, range and robustness. Analytical method validation includes all procedure and checks required to prove the reliability of a method for quantitative determination of concentration of an analyte or series of analyte in a given sample. The conventional and novel pharmaceutical dosage forms and gives an insight to possible alternatives in drug dissolution testing design. The aim of this review is to represent all the potential standardized test methods development and validation of pharmaceutical dosage form by using RP-HPLC which are analyzed the accuracy of the dissolution sample of the dosage form.