Reversed Phase High Performance Liquid Chromatographic Method for Simultaneous Estimation of Pregabalin and Aceclofenac in Tablet Formulation (Acenac-N)

摘要

Pregabalin (PRG) is a new antiepileptic drug and Aceclofenac (ACE) is a potent non-steroidal anti-inflammatory drug. These drugs in combination are used for treatment of partial seizures and neuropathic pains. A simple and precise assay method by RP-HPLC was developed and validated for estimation of PRG and ACE in Acenac-N tablet. Analyses of commercial tablet, Acenac-N were performed using JASCO Isocratic HPLC system at 248 nm on a reverse phase column HiQ sil C18HS (4.6 × 250 mm, 5μm), a mobile phase; methanol: phosphate buffer (70:30 v/v, PH 3). The validation aspects were selectivity, linearity, precision, accuracy and quantification limit. Linearity, 5-25 μg/mL for PRG and ACE respectively, provided determination coefficients (R 2 ) of 0.998 and 0.994 respectively, for PRG and ACE and proved precise since the RSD% was less than 2%. The recoveries obtained ranged from 99.10% to 100.90% for both of the drugs with RSD% less than 2%. The LOD for PRG and ACE was found to be 0.270 μg/mL and 0.039 μg/mL respectively. The LOQ was found at 0.818 μg/mL and 0.120 μg/mL respectively for PRG and ACE. In this study, the optimization of mobile phase, flow rate, injection volume and wavelength were achieved. The retention time for PRG and ACE was 3.241 and 6.581 min respectively. Drug content of the Acenac-N tablet was found to be 99.53% and 100.12% respectively for PRG and ACE. The method was validated as per the ICH guidelines. This method is precise, accurate and easy to analysis PRG and ACE in tablets.