Abstract

DEVELOPMENT AND VALIDATION OF ANALYTICAL METHODS FOR SIMULTANEOUS ESTIMATION OF MEFENAMIC ACID AND ITS MAJOR IMPURITY 2, 3-XYLIDINE (2, 3-DIMETHYLANILINE)

Nisha B. Thummar* and Dr. Parula B. Patel

ABSTRACT

To develop and validate of analytical methods for simultaneous estimation of mefenamic acid and its major impurity 2,3-xylidine (2,3-dimethylaniline). In UV- Spectrophotometric methods, absorbance correction method absorbance was measured at 350 nm mefenamic acid (at 350 nm absorbance of 2, 3-xylidine is zero) and 235.20 nm 2,3-xylidine. In RP- HPLC method for mefenamic acid and 2,3-xylidine chromatographic separation was carried out on Waters spherisorb®, 5μm, ODS (250 mm L × 4.6 mm Ø) in size using mobile phase methanol : water (70:30 % v/v), flow rate 1 ml/min, and detected at 233 nm using PDA detector. Detection linearity was established in concentration range Mefenamic acid 10-50μg/ml and 2,3-Xylidine 1-5μg/ml for absorbance correction method and Mefenamic acid 80-120μg/ml and 5-25μg/ml 2,3-Xlidine for RP-HPLC method. Validation of developed method was performed according to ICH Q2R1guidline.

Keywords: Mefenamic acid, 2, 3-Xylidine, Meftal tablet, UV-Spectroscopic method, RP-HPLC method.