科研之友
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摘要
This work describes the development and validation of an LC stability-indicating method for the quantitation of desonide lotion, followed by a photostability study of the same pharmaceutical form under exposure to UVA light (352nm). The method used a RP-18 column, mobile phase composed of a methanol:acetonitrile:water pH 5.0 mixture (50:10:40) and detection at 244nm. The method validation followed the ICH guidelines, and its robustness was evaluated by a factorial design (2(4)). All the validation requirements were met, evidenced by good linearity (r>0.9999, in the range from 10 to 100 mu g/mL), accuracy (mean recovery 100.09%), precision (intra-day RSD 1.4 and 1.75%; inter-day RSD 1.59%), robustness, and specificity. The last one was indicated by high peak purity index in all the stress conditions adopted and by good resolution between the analite peak from adjacent peaks (R>2.0). These data confirm the procedure suitability to routine analysis and stability studies. About the photodegradation of desonide lotion, it can be described by second-order kinetics with a t90% value of 1.58h under the experimental conditions employed in this study. The low photostability of the product evaluated justifies the need for further studies aimed at improving the formulation in order to ensure safety and therapeutic efficacy.
- 出版日期2014-8-27
