Résumé
The aim of the present study was to develop and validate an analytical method for the estimation of nepafenac as a raw material as well as in dosage form [suspension] by using reverse phase high performance liquid chromatographic [RP-HPLC]
The target was to obtain an easy, rapid, reproducible as well as a rugged method. The HPLC system that was used in the proposed study was LC-20AD liquid chromatograph equipped with SPD-20A UV-VIS detector
The separation was performed on CIS column which was attached with loop 20ul. Elution was done at ambient temperature with a mobile phase consisting of acetonitrile: Water [40: 60v/v] at a flow rate of Iml/min and at a wavelength of 254 nm. The proposed method was validated as per the ICH guidelines. The retention time for nepafenac was 7.49 minutes [% CV=0.0076]
The percentage coefficient variation [CV] of six consecutive peak areas of injections was 0.34% with tailing factor 1.76. The peak area responses were linear within the concentration range of 0.078-20.0ug/ml (R[2]=0.9993]
The sensitivity of the method could be evaluated by limits of detection [LOD] [0.0195ug/ml] d limits of quantitation [LOQ] [0.039ug/ml]
Nepafenac drug is s in its diluent that could see by intra-day [% CV I =0.45-1.96] and inter-day variation [%CV=0.173-1.898%]
The accuracy and recovery results of 80%, 100% and 120% were 97.40% to 102.10% with % CV of 0.3201% to 1.3496%. The robustness and ruggedness of the method are significantly broader and is reproducible. It could be used as a more convenient, efficient, easy and time saving method for the analysis of drug in raw material as well as in dosage form [ophthalmic suspension]