Purity determination of gynalgin bactericidal tablets with HPLC method.

Wanda Białecka, Anna Kulik, Marzena Podolska, Barbara Kwiatkowska-Puchniarz, Aleksander Mazurek

Index: Acta Pol. Pharm. 70(1) , 51-8, (2013)

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Abstract

The study was aimed at developing a simple HPLC method for the determination of the content of impurities in Gynalgin, a two-component preparation. A satisfactory separation was performed on 250 x 4.6 mm Symmetry C8 column in a gradient elution system: mobile phase A--acetonitrile/buffer, pH 5.5 in 10:90, v/v proportion, and mobile phase B--acetonitrile/buffer, pH 5.5 in 75:25 v/v proportion. Two wavelengths: 250 nm and 315 nm were used for detection. Validation confirmed that the method was linear in a required concentration range. The values of correlation coefficients for specific drug substances and the related impurities were as high as 0.999. The results of the purity tests proved that the method was sufficiently selective and precise.