Abstract
The article shows the results of a study of pharmaceutical equivalence of generic suppositories using Dissolution test. Objects: rectal suppositories of ketoprofen, diclofenac, indomethacin, paracetamol. Materials and methods: the Dissolution test was performed according to the method of United States Pharmacopoeia on the device Erweka DT 6, paddle apparatus (100 rpm), in dissolution medium of phosphate buffer solution (volume 900 ml, pH=7,2). Samples were collected after 15, 30, 45, 60 min after the start of the experiment. The quantity of ketoprofen, diclofenac, indomethacin, paracetamol was determined spectrophotometrically at wavelengths of 260 ±2 nm, 276 ±2 nm, 318 ±2 nm, 243 ±2 nm, respectively. As the reference solution used phosphate buffer solution (pH=7,2). A comparative evaluation of the equivalence of dissolution profiles of the drugs was performed by using the coefficients of the difference (f1) and similarity (f2). The study established the equivalence of ketoprofen suppositories of two, diclofenac – four, indomethacin and paracetamol – three manufacturers.
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