Chromatographic Method HPLC for the Identification and Quantification of the Active Substances in a Multicomponent Drug Product

Marzena Podolska

Anna Kulik

Wanda Białecka

Barbara Kwiatkowska-Puchniarz

Aleksander Mazurek

Marzena Podolska

Anna Kulik

Wanda Białecka

Barbara Kwiatkowska-Puchniarz

Aleksander Mazurek

Z Zakładu Farmacji Podstawowej i Stosowanej Narodowego Instytutu Leków w Warszawie

Abstract

The aim of this study was to develop a HPLC method which allows the identification and determination of the content of metronidazole and chloroquinaldol in a drug product Gynalgin - vaginal tablets. Satisfactory results were obtained in two gradient systems. In the first method 250 cm diphenyl column and mobile phases were used ( A, containing 0.5 ml of 85% H3 PO4 in 1000 ml of deionized water, and B, containing THF/ACN/H2 O in ratio of 4:5:1). In the second method the researchers used C4 column of the length of 150 cm and the phases: A, containing 0.5 ml of 85% H3 PO4 in 1000 ml of deionized water which was brought to pH 6.0 with 10% NaOH, and B, containing ACN/ H2 O in ratio of 9:1. In both cases, phase flow of 1.5 ml / min and detection at a wavelength λ = 220 nm and λ = 315 nm were used. Conducted validation confirmed good selectivity, precision and accuracy of the methods. The correlation coefficients above 0.999 indicate a linear calibration curves for the active substances. Both systems can be applied in routine analysis of the drug product

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