Open AccessSTABILITY INDICATING RELATED SUBSTANCES METHOD FOR BISOPROLOL AND CILNIDIPINE IN BULK AND PHARMACEUTICAL DOSING TYPES AND ITS DEGRADENTS WERE CHARACTERISED BY USE OF LC-MS/MS
Author(s) -
Subba Rao Yarlagadda,
Subba Rao Mannam,
K. V Padmavathi,
Baby Padmini Jampani
Publication year - 2022
Publication title -
ymer
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.103
H-Index - 5
ISSN - 0044-0477
DOI - 10.37896/ymer21.02/69
Subject(s) - bisoprolol , chromatography , chemistry , dosage form , high performance liquid chromatography , pharmaceutical formulation , medicine , heart failure
A reliable, simple yet consistent RP-HPLC method has been developed and verified to combined dosage form of Bisoprolol, Cilnidipine, their relavant substances and characteristic of the degradants by LC-MS/MS. The process used was optimized by using X-Bridge phenyl column (150mmx4.6mm, 3.5 µ) with a gradient elution mode of mobile phase consists of methanol and 0.1% tri ethyl amine of pH-2.5. The developed RP-HPLC method shows strong linearity in the range of concentrations 2-30 µg/ml of Bisoprolol, 4-60 µg/ml of Cilnidipine and 0.1-1.5 µg/ml of Bisoprolol and Cilnidipine impurities. Percentage of regeneration and percentage RSD values were found to be within the allowable limit. The developed method was found to be applicable for routine analysis and utilized for the calculation of both active ingredients and their impurities in tablet dosage form