European Journal of Biomedical and Pharmaceutical Sciences

DEVELOPMENT AND VALIDATION OF STABILITY INDICATING RP-HPLC METHOD FOR SIMULTANEOUS ESTIMATION OF ACECLOFENAC, PARACETAMOL AND CHLORZOXAZONE IN TABLET DOSAGE FORM

Tejal R. Patel*, Dr. Anuradha G. Patel, Dr. Shailesh V. Luhar and Dr. Sachin B. Narkhede

ABSTRACT

To develop simple, accurate, precise, rapid and economical Stability Indicating RP-HPLC method for the Aceclofenac, Paracetamol and Chlorzoxazone in dosage form method included Shimadzu LC-2010, using Hypersil BDS- C18 (250* 4.6mm, 5μm) column and with mobile phase composition of Phosphate Buffer: Acetonitrile (80:20 % v/v)pH 5.5, at a flow rate of 1ml/min was used. Detection was carried out at 285 nm. Retention time of Aceclofenac, Paracetamol and Chlorzoxazone was found to be 10.093 min, 5.520 min and 7.023 min. For Stability Study Drug Were subjected to acid hydrolysis, alkaline hydrolysis, oxidative degradation and thermal degradation. The linear of the proposed method was investigated in the range of 5-15 μg/ml, 16.25-48.75 μg/ml and 12.5-37.5 μg/ml for Aceclofenac, Paracetamol and Chlorzoxazone. The limits of detection were 0.5473 μg/ml and 2.8318μg/ml and 1.8414μg/ml of Aceclofenac, Paracetamol and Chlorzoxazone and the limit of quantification were 1.6587μg/ml, 8.5813μg/ml and 5.5801 μg/ml of Aceclofenac, Paracetamol and Chlorzoxazone.

Keywords: Aceclofenac, Paracetamol, Chlorzoxazone RP-HPLC method, forced degradation, validation.