Development and Validation of a Discriminating In Vitro Dissolution Method for Oral Formulations Containing Satranidazole

H. Pawar, P. Joshi
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引用次数: 8

Abstract

The development of a meaningful dissolution procedure for drug products with limited water solubility has been a challenge to the pharmaceutical industry. Satranidazole (BCS Class II drug) is a new nitroimidazole derivative with potent antiamoebic action. There is no official dissolution medium available in the literature. In the present study, parameters such as saturation solubility in different pH medium, dissolution behavior of formulations, influence of sink conditions, stability, and discriminatory effect of dissolution testing were studied for the selection of a proper dissolution medium. Results of solubility data revealed that solubility of Satranidazole decreases with an increase in pH. Satranidazole showed better sink condition in 0.1 N HCl as compared to other media. The drug and marketed formulations were stable in the dissolution media used. An agitation speed of 75 rpm showed a more discriminating drug release profile than 50 rpm. Using optimized dissolution parameters (paddle at 75 rpm, 900 mL 0.1 N HCl) greater than 80% of the label amount is released over 60 minutes. UV-spectroscopic method used was validated for the specificity, linearity, precision, robustness, and solution stability. The method was successfully applied to granular formulations and also to marketed tablets containing 300 mg Satranidazole.
沙硝唑口服制剂体外溶出度鉴别方法的建立与验证
开发具有有限水溶性的药品有意义的溶出程序一直是制药工业面临的挑战。Satranidazole (BCS II类药物)是一种新的硝基咪唑衍生物,具有有效的抗阿米巴作用。文献中没有官方的溶解介质。本文研究了不同pH介质的饱和溶解度、配方的溶解行为、沉淀条件的影响、稳定性和溶解试验的判别效应等参数,以选择合适的溶解介质。溶解度数据表明,随着ph的增加,Satranidazole的溶解度降低,在0.1 N HCl中,Satranidazole的沉降条件较其他介质好。该药物和市售制剂在所使用的溶出介质中是稳定的。75转/分的搅拌速度比50转/分的搅拌速度更能鉴别药物释放。使用优化的溶解参数(桨速75 rpm, 900 mL 0.1 N HCl),大于80%的标签量在60分钟内释放。验证了紫外光谱法的特异性、线性度、精密度、鲁棒性和溶液稳定性。该方法成功地应用于颗粒制剂和市场上销售的含有300 mg沙硝唑的片剂。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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