Validation of the framycetin sulfate determination technique by HPLC in a Framidex medicinal preparation

Abstract

A method for determination of framycetin sulfate in a Framidex preparation (eye and ear drops) by HPLC-UV (λ = 365 nm) using 2, 4-dinitrofluorobenzene as a derivatizing agent has been developed The characteristics of analytical methods determined for the purpose of their validation and relevant criteria for the validity of validated methods with the goal of the quality control of drugs (pharmaceutical substances and drugs) are presented. According to the results of an intralaboratory experiment on the validation assessment of the method by the parameters of the specificity, limit of determination (LOD), linearity, precision and laboratory accuracy, it is shown that the LOD decreases by an order of magnitude, the correlation coefficient is not less than 0.99 correctness (average value — 97.5 – 102.5%; variation coefficient — not more than 2.0%; the confidence range should include 100% of values), convergence (variation coefficient — not more than 1.5%), intermediate precision (variation coefficient — not more than 1.5%). It is shown that the obtained values of metrological characteristics do not exceed the validation criteria and the developed method matches all the well-known requirements of GMP (Good Manufacturing Practice).