ABSTRACT

The aim of present study was to develop a simple, economical, precise and accurate RP-HPLC method along with its validation and to perform the stability indicating study for the estimation of methylergometrine maleate in formulation of injection. RP-HPLC method was developed by using Phenomenex Luna (c18 (2), 250 x 4.6 mm, 5 ?) and a combination of ammonium acetate: acetonitrile: in the ratio of 70:30 v/v as mobile phase, adjusted to pH 6.5 by glacial acetic acid. The developed method was validated by showing the results of various validation parameters which are within the limits. Linearity ranges were 12-28 ?g/ml, correlation coefficient was 0.9979 and mean recovery was found to be 99.79%. Further, stability indicating study has been performed and it showed positive results for acid degradation, alkali degradation, oxidation and sun-light exposure. Interferences of impurity peak were evaluated and found to be within limit. The developed method was found to be simple, sensitive, accurate and precise for analysis of methylergometrine maleate. The method can be adopted for analysis of drug in pharmaceutical dosage forms. Keywords: Stability, HPLC, Injectable, Degradation
Publication date: 01/03/21

https://ijbpas.com/pdf/2021/March/MS_IJBPAS_2021_5408.pdf

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https://doi.org/10.31032/IJBPAS/2021/10.3.5408