Abstract

ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR DETERMINATION OF OXCARBAZEPINE IN FORMULATED PRODUCT BY USING RP-UPLC

Anubhav Kumar*, Rajnish Kumar, Narendra Pratap Singh, Md. Nazre Heyat

ABSTRACT

A simple, specific and accurate reverse phase ultra-performance liquid chromatographic (RP-UPLC) method was developed for the determination of Oxcarbazepine in the tablet dosage forms. The chromatographic separation was achieved on BEH C-18 (2.1 x 50mm) 1.7 um particle size and the mobile phase containing acetonitrile with 5mM ammonium acetate for Oxcarbazepine. The run time was 2.50 min and the retention time of Oxcarbazepine was 1.35. The detection was carried out 214nm using photo diode array detector (PDA) with a flow rate 0.6 ml/min. The linearity of Oxcarbazepine was in the range 50-250 ppm with correlation coefficient 0.9999. The recovery was found in the range (100±10%). The developed method was validated as per International Conference on Harmonization guidelines (ICH) with respect to specificity, linearity, accuracy, precision, ruggedness and robustness.

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