Abstract

Development and validation of new RP-HPLC method for determining impurity profiling in proguanil hydrochloride drug as well as it�s tablet dosage form

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

A simple rapid, sensitive, accurate, precise and reproducible high performance liquid chromatographic method has been developed to estimate impurity profile for Proguanil hydrochloride 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 mobile phase constituted of buffer and methanol (42:58 % v/v). The buffer was composed of 4.0g hexane-1-sulphonic acid, sodium salt and 10 mL of glacial acetic acid in 790 mL of water. The dual wavelengths of the detection were 235 nm& 254 nm. The validation data showed that the method was sensitive, specific and reproducible for the impurity determinations of proguanil hydrochloride in dosage as well as in bulk form. The method was linear from 0.075μg/mL to 0.75μg/mL for Proguanil hydrochloride and it’s impurities A, C & D. The accuracy of the method was found to be 100.21% for impurity A, 99.76% for impurity C and 100.21% for impurity D. Inter and intraday assay relative standard deviation (RSD) were found less than 3.01% in drug form and 2.77% in tablet dosage form for impurity A, less than 3.03% in drug form and 3.03% in tablet dosage form for impurity C and less than 2.34% in drug form and 3.62% in tablet dosage form for impurity D. The proposed method provided an accurate and precise analysis of impurity A, C & D in Proguanil hydrochloride Drug form as well as in pharmaceutical dosage form

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