Published 2025 | Version v1

Development and validation of UV spectrophotometric method for estimation of stiripentol

Description

A rapid, specific and economic UV spectrophotometric method has been developed using a solvent, pH 1.2 buffer for the estimation of Stiripentol at a predetermined λmax of 264 nm. Validation was conducted according to ICH guidelines. This method shows linearity between the ranges 5-25µg/ml with correlation coefficient (R2), 0.9988. The % recovery was found to be in the range of 98-102%. Sensitivity was also confirmed with a limit of detection (LOD) of 2.4322 µg/ml and a limit of quantitation (LOQ) of 7.3703 µg/ml, indicating that even small quantities of stiripentol can be accurately measured. The low values of % RSD are indicative of the reproducibility of the method. The method can be employed for the routine analysis of stiripentol in the bulk and in the pharmaceutical dosage form.

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