Open AccessANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR KNOWN AND UNKNOWN IMPURITIES PROFILING FOR CARVEDILOL PHARMACEUTICAL DOSAGE FORM (TABLETS)
Author(s) -
Nitin Mahajan,
Suparna Deshmukh,
Mazahar Farooqui
Publication year - 2021
Publication title -
international journal of current pharmaceutical research
Language(s) - English
Resource type - Journals
ISSN - 0975-7066
DOI - 10.22159/ijcpr.2021v13i6.1922
Subject(s) - dosage form , chromatography , impurity , chemistry , carvedilol , acetonitrile , pharmaceutical formulation , high performance liquid chromatography , analytical chemistry (journal) , medicine , heart failure , organic chemistry
Objective: The aim of the research work to develop a simple, sensitive, rugged, robust and specific novel gradient stability indicating reverse phase HPLC method for quantitative determination of known and unknown impurities profiling of Carvedilol pharmaceutical dosage forms (Tablets).
Methods: Chromatographic separation has been achieved on an Inertsil ODS 3V column (150 mm x 4.6 mm, 5μm) with mobile phase consisting Mobile phase-A (Water, Acetonitrile and Trifluroacetic acid in the ratio of 80:20:0.1 v/v/v respectively and pH adjusted to 2.0 with dilute potassium hydroxide solution) and Mobile phase-B (Water and acetonitrile in the ratio of 100:900 v/v respectively) delivered at flow rate of 1.0 ml min-1 and the detection wavelength 240 nm. The column compartment temperature maintained at 40 °C.
Results: Resolution between Carvedilol and its impurities has been achieved greater than 1.5. The developed method was validated as per ICH guidelines. Analytical method found Precise, Linear, accurate, specific, rugged and robust.
Conclusion: Developed and validated novel analytical method can be used to for impurity profile analysis of Carvedilol Pharmaceutical dosage form (Tablets).