Abstract

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

Naresh Chandra Reddy M., Chandra Sekhar K., Vijaya Babu P.,
Naresh Kumar Katari*

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.

Keywords: Asenapine, inertsil C8 column, reverse phase HPLC, method development & validation, related substances.