Development and validation of the method quantitative determination of enisamium iodide for the assessment of dissolution profile of antiviral agent

Abstract

Assessment of the dissolution profiles is an important tool for characterization of solid drug products which need to be examined both at the stage of pharmaceutical development, and throughout their life cycle. It is necessary to control the release of the active substance from the dosage form after changes which are related to variation of drug product composition or technology used. The aim of this work was to develop and validate a method for the study of dissolution profiles of the antiviral agent enisamium iodide, tablets. The liquid chromatograph Agilent 1260 (USA) equipped with degasser, four-channel pump, autosampler, chromatographic column thermostat and diode area detector was used. The chromatographic column Zorbax Eclipse XDB-C18, with dimensions 150 × 4.6 mm, filled by octadecylsilane sorbent, with a particles size of 5 μm, was used. The mobile phase is a mixture of a buffer solution of pH 2.5 containing sodium octane-1-sulfonate in an amount of 0.1%, water, acetonitrile (30:35:35 v/v/v). The dissolution tester ERWEKA DT 820 (Germany) was also used. During the validation such parameters as specificity, accuracy, precision and robustness were confirmed. The correlation coefficients of linear regression (r) between the entered and found values for enisamium iodide is greater than 0.995. Stability of the reference solutions and test solutions at storage at room temperature for 24 hours has been confirmed. The developed HPLC method of the quantitative determination of enisamium iodide can be used for study of the dissolution profiles of enisamium iodide tablets.