DEVELOPMENT AND VALIDATION OF A REVERSED PHASE UHPLC METHOD FOR SIMULTANEOUS DETERMINATION OF DICLOFENAC, PARACETAMOL AND CHLOROZOXAZONE IN BULK AND PHARMACEUTICAL DOSAGE FORM
Barnali Gogoi, Ripunjoy Bordoloi, Himakshi Baishya* and Dr. Partha Jyoti Gogoi
ABSTRACT
The purpose of this present work is to develop and validate a simple, linear, accurate and precise reversed phase U-High Performance Liquid Chromatography method for the simultaneous determination of Diclofenac Paracetamol and Chlorozoxazone in tablet dosage form (fixed dose combination formulation). For this, the analysis was carried out by High Performance Liquid Chromatography using U-HPLC System (Thermo- Dionex) equipped with an UV detector and stainless steel column (25cm × 4.6mm × 5μm) packed with octadecylsilane chemically bonded to porous silica column. The mobile phase contain buffer, adjusted to pH 7.5 with 1(M) sodium hydroxide and Acetonitrile in the ratio of 60:40 v/v with a flow rate of 1.5 mL/min and detection wavelength 272 nm. The retention time of Paracetamol Diclofenac and Chlorozoxazone was found to be 1.698, 2.368 and 3.528 respectively. The method was found to be linear in the concentration range of 10-50 μg/mL for Diclofenac, 100-500 μg/mL for Paracetamol and 100-500 μg/mL for chlorozoxazone with correlation coefficient of 0.993, 0.999 and 0.994 for the three drugs respectively. The %RSD of 0.660, 0.897 and 0.790 for intra-day and 0.589, 0.856 and 0.768 for inter-day precision, respectively for of diclofenac, paracetamol and chlorozoxazone suggest the precision of the method as all these values are less than 2%. The method has shown good, consistent recoveries for of diclofenac (109.52), paracetamol (105.73) and chlorozoxazone (107.64). The method was found to be accurate, precise, specific, robust and linear for the determination of diclofenac, paracetamol and chlorozoxazone in Pharmaceutical dosage form.
Keywords: UHPLC; Validation, Diclofenac, Paracetamol, Chlorozoxazone.
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