Development and Validation of a Dissolution Method with Spectrophotometric Analysis for Diacerhein Capsules

Abstract

The aim of this work was to develop and validate a dissolution test for diacerhein in capsules using spectrophotometric method. The dissolution established conditions were: 900 mL of sodium phosphate buffer pH 7.0 with 0.75 % of sodium lauryl sulphate as dissolution medium, using a basket apparatus at a stirring rate of 50 rpm. The drug release was evaluated by UV spectrophotometric method at 258 nm. The method was validated to meet requirements for a global regulatory filing. The validation included specificity, linearity, precision and accuracy. In addition, filter suitability and drug stability in medium were demonstrated. The comparison of the obtained dissolution profiles of capsules, obtained from three different brands (denominate product A, B and C) of 50 mg diacerhein, was performed and the results showed no significative difference among the products.

Modern approaches to the validation of the pharmacopoeial dissolution test

“…Preference is given to using the DF-placebo itself, especially for validation of a test procedure for a timed-release DF, because the tablet-placebo or capsule-placebo will constantly release excipients, just like the finished DF [5,11]. The specificity of either placebo-capsules or separately on capsule shells and the mixture of excipients contained within the capsules is allowed for validation of the Dissolution test procedure for capsules [13]. Then interference from the placebo on the analysis procedure of the active ingredient is determined, i.e., the UV spectrum is recorded or chromatography is performed.…”

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“…Several analytical methods have been reported for estimation of PCM which include spectrophotometry [5][6][7] , HPLC 8 , thin layer chromatography 9, 10 and voltammetry 11 . The analytical methods reported for estimation of PIX are spectrophotometry [12][13][14] , HPLC [15][16][17] , LC-MS 18 and fluorimetry 19 .…”