Development of Validated UV Spectrophotometric Stability Indicating Method for Estimation of Desloratadine from Its Tablet Dosage Form

Author(s): A B Roge*, G R Shendarkar, M H Ghante and N B Ghiware

Abstract: A novel simple, reliable, rapid and accurate UV spectrophotometric stability indicating method (SIM) was developed for estimation of Desloratadine from its tablet dosage form. The study was carried out at 242 nm. Desloratadine has shown linear absorbance over the concentration range of 5-30 μg/mL with R2 value 0.999. The slope and intercept equation y = 0.045x + 0.013 were used for determination of concentrations of test solution. The proposed method was validated as per ICH Q2 (R1) guidelines for various parameters e.g. precision, accuracy, limit of detection (LOD), limit of quantification (LOQ) and linearity and range. Results of validation study have shown compliance with criteria of ICH guidelines. Relative standard deviation was found less than 2% and recovery was found in range 99.12 – 99.90 %. Method was very sensitive as LOD and LOQ were found to be 0.121 μg/mL and 0.366 μg/mL respectively. Stability indicating potential was studied by analyzing sample subjected to various stress conditions like hydrolysis, oxidation, photo degradation and thermal degradations. Proposed method reveals that Desloratadine was found unstable at hydrolytic and oxidative stress conditions.

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