Development and validation of new RP-HPLC method for determining impurity profiling in olmesartan medoxomil drug as well as in tablet dosage form

N; ini R Pai; Seema S. Sawant

Abstract

Development and validation of new RP-HPLC method for determining impurity profiling in olmesartan medoxomil drug as well as in tablet dosage form

Author(s): Nandini R Pai and Seema S. Sawant

A simple, rapid, sensitive, accurate, precise and reproducible high performance liquid chromatographic method was developed to estimate impurity profile for Olmesartan medoxomil in drug as well as in tablet dosage form. The HPLC analysis used a reversed phase Kromasil C18 (150 x 4.6mm, 5μm) column and a mobile phase constituted of buffer and acetonitrile (60:40 % v/v). The buffer was composed of 4.7 g of sodium dihydrogenorthophosphate and 1 mL of triethyl amine in 1000 mL of water and the pH of the solution was adjusted to 4.0± 0.05 with orthophosphoric acid. The wave length of the detection was 225 nm. The validation data showed that the method is sensitive, specific and reproducible for the impurity determination of olmesartan in the dosage form. The method was found to be linear from 2 μg/mL to 7 μg/mL for Olmesartan medoxomil and from 0.25 μg/mL to 7 μg/mL for olmesartan Acid Impurity. The accuracy of the method was found to be 100.73% for olmesartan acid impurity. Inter and intraday assay relative standard deviation (RSD) was less than 0.71% in drug form and 1.10% in tablet dosage form for Olmesartan acid impurity. The proposed method provided an accurate and precise analysis of Olmesartan acid impurity in Olmesartan medoxomil Drug form as well as in pharmaceutical dosage form

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