Stability-Indicating RP-HPLC Method for Simultaneous Estimation of Chlorzoxazone and Paracetamol in Tablet Dosage Form

Chaudhari Bharat G; Prajapati Hetal R

Authors

Chaudhari Bharat G Department of Quality Assurance, S. K. Patel College of Pharmaceutical Education and Research, Ganpat University, Ganpat Vidyanagar, Mehsana, Gujarat, India.
Prajapati Hetal R Department of Quality Assurance, S. K. Patel College of Pharmaceutical Education and Research, Ganpat University, Ganpat Vidyanagar, Mehsana, Gujarat, India.

Keywords:

Chlorzoxazone, Paracetamol, RP-HPLC, Stability indicating, Validation, Recovery

Abstract

A simple, precise, and rapid stability-indicating RP-HPLC method has been developed and validated for simultaneous
estimation of Chlorzoxazone (CHL) and Paracetamol (PCM) in tablet dosage form using X Terra® C18 column (150 mm ×
4.6 mm id, 5 ?m particle size) as stationary phase, Acetonitrile: Methanol: HPLC grade water [20: 10: 70 v/v/v] as a mobile
phase with a flow rate of 0.7 ml/min. Quantification was achieved with a Photo Diode Array detector at 270 nm. The retention time for Paracetamol and Chlorzoxazone was found to be 2.822 and 5.377 min. Chlorzoxazone and Paracetamol were exposed to acid/base hydrolytic, oxidative, thermal, and photolytic stress conditions, and stressed sample were analyzed by proposed method. There were no other co-eluting, interfering peaks from excipients, impurities, or degradation products due to variable stress conditions, and the method is specific for the estimation of Chlorzoxazone and Paracetamol in the presence of degradation products. The linearity was obtained in the concentration range of 5-50 ?g/ml for both drugs. The mean recoveries were 100.83 and 100.50% for CHL and PCM, respectively. The proposed method can be useful in routine quality control of bulk manufacturing and pharmaceutical dosage forms.