Development and validation of stability-indicating UV spectrophotometric method for determination of Apremilast in bulk and pharmaceutical dosage form
Journal Title: Indian Journal of Research in Pharmacy and Biotechnology - Year 2017, Vol 5, Issue 1
Abstract
A simple, precise, accurate, cost effective stability indicating UVSpectrophotometric method has been developed for the estimation of Apremilast in bulk and tablet dosage form. Apremilast shows highest λmax at 229.3 nm. Beer's law (linearity response) was found over a concentration range of 2 -10 μg /mL with good correlation coefficient (r2 = 0.9983). The Detection limit (DL) & Quantitation limit (QL) were found to be 0.00271 mcg/mL and 0.0082 mcg/mL respectively. The results of the Apremilast recovery analysis were found to be 96.80±0.0003 to 98.28±0.0003. Percentage assay of Apremilast tablets (Otezla) got more than 99.93 %. Apremilast was subjected to alkali, acid, oxidation, photolytic, UV light degradation. Apremilast is more unstable in alkaline, acidic, and stable in thermal and ultra violet (UV) light irradiation. The Proposed spectrophotometric method was validated as per the ICH Q1A (R2) guidelines. While estimating the Apremilast in tablet formulation there was no interference of additives & excipients. Hence this method can be safely be employed for the routine quality control analysis of Apremilast in bulk and tablet dosage form.
Authors and Affiliations
Panchumarthy Ravisankar, MD. Shaheem Sulthana, P. Srinivasa Babu
Keywords
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