A Validated Stability Indicating RP-HPLC Method Development for The Estimation of Pomalidomide In Bulk and Pharmaceutical Dosage Form

Author(s): Santhosh Illendula*, Muthyam Sanjana, V. Shirisha, K.N.V. Rao, Rajeswar Dutt

Abstract: A simple, rapid, precise, accurate and sensitive reverse phase liquid chromatographic method has been developed for the determination of Pomalidomide in bulk and pharmaceutical dosage form dosage form. The chromatographic method was standardized using Develosil ODS HG-5 RP C18, 5μm, 15cm x 4.6mm i.d. column with UV detection at 228nm and mobile phase composition of Methanol: Phosphate buffer = 60:40 ratio at a flow rate of 1.0 ml/ min. The proposed method was successfully applied to the determination of Pomalidomide in bulk and pharmaceutical dosage form. The method was linear over the range of 0-14μg/ml. The recovery was in the range of 98% to 102% and limit of detection was found to be 0.07 μg/ml and quantification was found to be 0.21 μg/ml. Different analytical performance parameters such as precision, accuracy, limit of detection, limit of quantification and robustness were determined according to International Conference on Harmonization (ICH) guidelines.

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