Development and Validation of a RP-HPLC Method for Simultaneous Determination of Betamethasone and Sodium Benzoate in Oral Liquid Pharmaceutical Formulation
Laboratory of Protein Engineering and Bioactive Molecules, National Institute of Applied Sciences and Technology (INSAT), Tunis, 1Department of Research and Development, Laboratory of Sterile Drugs (Medis), Nabeul, Tunisia
Laboratory of Protein Engineering and Bioactive Molecules, National Institute of Applied Sciences and Technology (INSAT), Tunis, Tunisia E-mail: [email protected]
The present work reports development and validation of a high-performance liquid chromatography diode array detection procedure for the determination of betamethasone and sodium benzoate in pharmaceutical formulation. Effective chromatographic separation of betamethasone and sodium benzoate was achieved using Nova-pack-C18 (150×3.9 mm, 4 µm) column with gradient elution of the mobile phase composed of 50 mM monobasic potassium phosphate buffer (pH 2.9) and acetonitrile. The elution was a three step gradient elution program with 25% acetonitrile and 75% buffer at 0 min further acetonitrile concentration changed linearly to 45% up to 25 min, followed by changing acetonitrile to 25% up to 35 min. The correlation coefficient for betamethasone and sodium benzoate were 0.9999 and 0.9999, respectively. The developed method was statistically validated with regard to specificity, linearity, accuracy (recovery) and precision.