ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR KNOWN AND UNKNOWN IMPURITIES PROFILING FOR CARVEDILOL PHARMACEUTICAL DOSAGE FORM (TABLETS)

NITIN MAHAJAN; SUPARNA DESHMUKH; MAZAHAR FAROOQUI

doi:10.22159/ijcpr.2021v13i6.1922

Authors

NITIN MAHAJAN Post Graduate and Research Centre, Department of Chemistry, Maulana Azad College of Arts, Science and Commerce, Dr. Babasaheb Ambedkar Marathwada University, Aurangabad, Maharashtra, 431001, India
SUPARNA DESHMUKH Department of Chemistry, S. K Gandhi college, Kada, Tal: Asthi, Dist: Beed, Maharashtra, 414202, India
MAZAHAR FAROOQUI Department of Chemistry, S. K Gandhi college, Kada, Tal: Asthi, Dist: Beed, Maharashtra, 414202, India

DOI:

https://doi.org/10.22159/ijcpr.2021v13i6.1922

Keywords:

Carvedilol, Method development, Validation, Impurities, Related substances, ICH guidelines

Abstract

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).

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