Open AccessReview Article of Dissolution Test Method Development and Validation of Dosage Form by Using RP-HPLC
Author(s) -
Prachi Barsagade,
Roshan Khetade,
Kalyani Nirwan,
Tikesh Agrawal,
Santosh Gotafode,
Updesh Lade
Publication year - 2021
Publication title -
international journal of pharmaceutical sciences review and research
Language(s) - English
Resource type - Journals
ISSN - 0976-044X
DOI - 10.47583/ijpsrr.2021.v70i01.005
Subject(s) - dissolution testing , analyte , dosage form , repeatability , chromatography , dissolution , high performance liquid chromatography , biopharmaceutical , chemistry , detection limit , biopharmaceutics classification system , biology , genetics
Dissolution is precise test method used for evaluating drug release of solid and semisolid dosage forms. It is the process by which asolid solute enters a solution. For the analysis of dissolution test method development, the Reverse Phase High Performance LiquidChromatography is used, and it is the modern of column chromatography. In the reverse phase partition HPLC the relative polarity ofthe 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 drugbioavailability. The article represents the current updates in dissolution testing methods by using Reverse Phase High PerformanceLiquid Chromatography. The validation parameters explain for the analysis of sample is accuracy, precision, repeatability, detectionof limit, quantitative limit, linearity, range and robustness. Analytical method validation includes all procedure and checks requiredto 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 testingdesign. The aim of this review is to represent all the potential standardized test methods development and validation ofpharmaceutical dosage form by using RP-HPLC which are analyzed the accuracy of the dissolution sample of the dosage form.