SEPARATION AND DETERMINATION OF THE S-ISOMER OF (10-CAMPHORSULFONYL) OXAZIRIDINE IN A BULK DRUG SUBSTANCE BY NORMAL-PHASE LIQUID CHROMATOGRAPHY

Abstract

Objective: To develop novel, simple and accurate enantiomeric separation of (10-Camphorsulfonyl) oxaziridine by normal-phase high-performance liquid chromatographic method as per ICH guidelines.

Methods: The S-isomer and R-isomer of (10-Camphorsulfonyl) oxaziridine were baseline resolved on a Chiralcel OD-H (250 x 4.0 mm i. d, 5 mm) column using a mobile phase system containing n-Hexane: ethanol: trifluoroacetic acid (90:10:0.1 v/v/v.) at detector wavelength 210 nm and column temperature 30 °C. The chromatographic resolutions between S-isomer and R-isomer were found three. The developed method was extensively validated according to ICH guidelines.

Results: Good linearity was observed for S-isomer over the concentration range of 900–9000 ng/ml, with the linear regression (Correlation coefficient R = 0.999) and proved to be robust. The limit of detection and limit of quantification of S-isomer was found to be 400 and 900 ng/ml, respectively for 20 ml injection volume. The percentage recovery of S-isomer was ranged from 97.0 to 102.0 in bulk drug samples of (10-Camphorsulfonyl) oxaziridine. (10-Camphorsulfonyl) oxaziridine sample solution and mobile, phase was found to be stable for at least 48 hours. The proposed method was found to be suitable and accurate for the quantitative determination of S-isomer in bulk drugs.

Conclusion: A novel, simple and accurate normal phase LC method was described for the enantiomeric separation of 10-Camphorsulfonyl Oxaziridine is precise and specific.