Development and Validation of RP-HPLC Method for Simultaneous Estimation of Ibuprofen and Chlorzoxazone in Synthetic Mixture
ABOUT AUTHORS
Anil C. Patel*, Dr Paresh U. Patel , Rinku B. Patel
Department of Quality Assurance, S. K. Patel College of Pharmaceutical Education and Research,
Ganpat University, Ganpat Vidyanagar – 384012, Mehsana, Gujarat, India.
*anilpatel002@gmail.com
ABSTRACT
A novel, precise, accurate and rapid isocratic reversed-phase high performance liquid chromatographic/ultraviolet (RP-HPLC/UV) method was developed, optimized and validated for simultaneous determination of Ibuprofen and Chlorzoxazone. The method showed adequate separation for Ibuprofen and Chlorzoxazone and best resolution was achieved with ACE 5 C18 column (150 mm × 4.6 mm i.d, 5 μm particle size) using Acetonitrile-Phosphate buffer pH 3.5 - Methenol (20:20:60, v/v; pH adjusted to 3.5 with O-phosphoric acid and TEA(Tetra ethyl amine) as a mobile phase at a flow rate of 0.7 ml/min and wavelength of 221 nm. The calibration curves were linear over the concentration ranges of 2-30 μg/ml for Ibuprofen and Chlorzoxazone. The limit of detection (LOD) and limit of quantification (LOQ) for Ibuprofen were 0.96 and 2.92 μg/ml while for Chlorzoxazone were 0.69 and 2.09 μg/ml, respectively. All the analytes were separated in less than 6.0 min. The proposed method could be applied for routinelaboratory analysis of Ibuprofen and Chlorzoxazone in pharmaceutical dosage form. Methods were validated statistically and recovery studies were carried out. The proposed methods have been applied successfully to the analysis of cited drug either in pure form or in synthetic mixture of both drugs with good accuracy and precision. The method herein described can be employed for quality control and routine analysis of drugs in pharmaceutical formulations.
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