Development and Validation of Spectrophotometric Method for Analysis of Topiramate
Rohit Udhav Bharti*, Vandana Gawande
Selective, inexpensive and validated method was developed and optimized for determination of antiepileptic drug, Topiramate in drug substance and drug product as well as in the presence of pyridine. The method is based on the reaction of the primary amino group of Topiramate with Ninhydrin reagent in ethanolic medium in the presence of 10% pyridine solution. The colored product was measured at 568 nm. The linearity range was found to be 50 – 300 μg mL-1 with mean recovery 98-102%. All variables affecting the reaction conditions were thoroughly studied. The results were found to agree statistically, the method was validated according to the ICH guidelines. The proposed method is practical and valuable for their in quality control laboratories for analysis of Topiramate.
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