THE INVESTIGATION OF THE DICLOFENAC SODIUM DISSOLUTON KINETICS FROM THE INDUSTRIAL PRODUCTION SUPPOSITORIES

The aim of this work was the development of Dissolution profile test for rectal diclofenac sodium suppositories, the validation of analytical proce-dure and the using of the validated procedure for the comparative analysis of industrial suppositories. The optimal conditions for the dissolution test and the study design have been chosen: apparatus I (Basket apparatus); 100 basket rotations per minute; the dissolution medium - 500 ml of purified water free from dissolved air; sampling time - 5, 10, 15, 20, 30, 60, 70, 80, 90 minutes; UV spectro-photometric analyzing dissolution test samples (in the maximum of diclofenac sodium absorption at the wavelength 278 ± 2 nm). The validation has been performed according to the following parameters: specificity, linearity, accuracy, precision, range. All the validation char-acteristics of the analytical procedure have been determined under the conditions of the Dissolution test. The evaluated placebo interference of 1,24 % has not exceeded the critical value of 2 %. The linearity study has been carried out in the range of diclofenac sodium concentrations from 10 to 135 % of the nominal amount in steps of 10 %. The measured values of absorbance have been on the re-gression curve or have been evenly distributed on both sides of it; the deviation has not exceeded of 8 %. The calculated correlation coefficient 0,99977 has demonstrated linearity. The validation characteristics, accuracy and precision (repeatability) have been evaluated by the results of three determinations at each of the three concentration levels: 55, 100 and 135 %. The measured recovery was 100,18 %, relative standard deviation was 0,38 %, systematic error – 0,18. So it has been shown that the analytical procedure for diclofenac sodium assay in the dissolution medium is specific, linear, highly accurate and reproducible. The quality of diclofenac sodium suppositories produced by domestic manufacturers has been investigated with such parameters as melting point, disintegration time of suppositories, uniformity of mass, particle size and quantitative content of diclofenac sodium. A dissolution profile test of diclofenac sodium suppositories of different producers has been carried out and nonequivalence of profiles due to the composition and properties of the excipients has been shown. The importance of hydroxyl value and melting point of used fat suppository bases has been highlighted.