A VALIDATED STABILITY-INDICATING NORMAL PHASE HPLC METHOD FOR THE DETERMINATION OF NAPROXCINOD ALONG WITH ITS CHIRAL AND ACHIRAL IMPURITIES.

Authors: Shiva Raj1, ¬K. Siva Kumari2,* and A. Narasimha Rao2

*E-mail: sivakumarik@drreddys.com

A novel stability-indicating normal phase liquid chromatographic (NP-LC) method was developed for the determination of purity of naproxcinod in the presence of its impurities and degradation products. This method is capable of separating all the related substances of naproxcinod along with its chiral and achiral impurities. This method can be also be used for the estimation of assay of naproxcinod. The method was developed using chiralpak IB (250mm×4.6mm, 5µm) column with immobilized stationary phase. n-Hexane, 2-propanol, acetonitrile and triflouro acetic acid in 97.5:2.5:0.0.2:0.2 (v/v/v/v) ratio was used as a mobile phase. The eluted compounds were monitored at 210 nm. naproxcinod was subjected to the stress conditions of oxidative, acid, base, hydrolytic, thermal and photolytic degradation. The degradation products were well resolved from main peak and its impurities, proving the stability-indicating power of the method. The developed method was validated as per International Conference on Harmonization (ICH) guidelines with respect to specificity, limit of detection, limit of quantification, precision, linearity, accuracy, robustness and system suitability.

Keywords : Naproxcinod, Development, Normal phase liquid chromatography, Stability-indicating, Chiral and achiral impurities.