Résumé
The aim of the study was to investigate the dissolution behavior of commercially available brands of metronidazole and to provide basic tool to evaluate the comparative effectiveness and interchangeability of generic brands under biowaiver conditions. The dissolution test for six brands of metronidazole 400mg tablets was performed and physical controls were analyzed. Basket Rack methods at 100rpm were used to estimate release pattern of drug. Pharmaceutical parameters of tablets were analyzed. In order to evaluate dissolution profiles, multiple point dissolution were performed and calculated 85.96 +/- 0.41 to 90.56 +/- 0.93 % within 15 minutes in pH 1.2,85.50 +/- 1.40 to 88.99 +/- 0.80% in pH 4.5 and 85.37 +/- 1.94 to 92.79 +/- 0.89% in pH 6.8 dissolution medium respectively. Five different kinetics have been studied to predict and evaluate the acceptability level of drug release. The results show that Hixson-Crowell, first-order and Weibull demonstrated the drug release with R2
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]