Validated High Performance Thin Layer Chromatographic Estimation of Aceclofenac in Bulk and Pharmaceutical Dosage Forms

Helen William, Dr. B. Parimala Devi, Jose Kurien, P. K Valsalakumari, C. K Mohandas

Abstract: A simple; precise; accurate and specific method is developed and validated for analysis of Aceclofenac in bulk and pharmaceutical dosage forms. The developed method used precoated Silica gel 60F254 as stationary phase and the mobile phase used was a mixture of Hexane: chloroform: methanol in the ratio (6: 2: 2). The RF value was 0.3. The detection of spots was carried out at 271nm. The calibration curve was found to be linear between 1 to 6 g/ml with a correlation coefficient of 0.9998. The proposed method was validated according to various ICH parameters like linearity; accuracy; precision; specificity; limits of detection; limits of quantification; range and solution stability. The accuracy was determined by recovery studies and found to be 98.35 to 100.43 %. Statistical analysis proved that the proposed method is suitable for the routine analysis of Aceclofenac in bulk and pharmaceutical formulations.

Keywords: Aceclofenac, HPTLC, Validation, ICH guidelines