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METHOD DEVELOPMENT AND VALIDATION OF RELATED SUBSTANCES IN ASENAPINE TABLETS BY REVERSE PHASE HPLC

Published On: March, 2016

Article Type: Research Article

Journal: World Journal of Pharmaceutical Research

DOI: 10.20959/wjpr20164-5767

Issue: 4 | Volume: 5 | Page No: 1653-1663

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Abstract

A novel RP-HPLC Quantification method was developed for estimation of Asenapine known impurities like its N-oxide, Des methyl, Des Chloro and Amide which, were separated on an Inertsil C8 column (250.0 mm x 4.60 mm; 5.0μ). Mixture of phosphate buffer (pH 6.8), water & acetonitrile as a mobile phase with a rate of flow 1 ml/minute was used; λ max at 220 nm. The developed method was validated all the parameters like linearity, specificity, limit of quantification (LOQ) and detection (LOD), precision, accuracy, ruggedness, filter variation, robustness & solution stability.

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