The current research work deals with the development Erlotinib cost of spectrophotometric method and its validation as per International Conference on Harmonisation (ICH) guidelines. MATERIALS AND METHODS Experimental Instrument and materials Instrument used were Schimadzu 1800 double beam UV/Visible Spectrophotometer and schimadzu 1600 analytical balance. Lafutidine pure drug was obtain from Ajanta Pharmaceuticals Ltd., Mumbai, India as gift sample with 99.9% (w/w) assay value and was used without further purification. All chemicals and reagents used were of analytical grade. Methodology Preparation of standard stock solution Standard drug solution of lafutidine was prepared by dissolving 10 mg lafutidine in 5 ml methanol this solution was transferred it to 10 ml volumetric flask and volume was made up to mark with distilled water to obtain stock solution of 1 mg/ml concentration.
Preparation of calibration curve Aliquots of 1�C5 ml portion of stock solutions were transferred to series of 100 ml volumetric flasks, and volume made up to mark with distilled water. Solutions were scanned in the range of 200�C400 nm against blank. The absorption maxima were found to be at 279 nm against blank. The calibration curve was plotted. The optical characteristics are summarized in Table 1. Table 1 Calibration curve parameter Preparation of sample solution The proposed method was applied to analyze commercially available lafutidine tablet. Ten tablets were weighed and powdered.
The amount of tablet powder equivalent to 10 mg of lafutidine was weighed accurately and transfer to 10 ml volumetric flask then 5 ml methanol was added and kept for 15 min with frequent shaking and volume was made up to mark with distilled water. The solution was then filtered through Whattman filter paper #41. This filtrate was diluted suitably with distilled water to get the solution of 10 ��g/ ml concentration. The absorbance was measured against solution blank. The drug content of the preparation was calculated using standard calibration curve. Amount of drug estimated by this method in Table 2. Table 2 Determination of accuracy by percentage recovery method RESULT AND DISCUSSION Linearity The linearity of the response of the drug was verified at 10�C50 ��g/ml concentrations. The calibration curve was obtained by plotting the absorbance versus the concentration data and was treated by linear regression analysis [Table 3].
The equation of the calibration curve for lafutidine obtained was y = 0.0100x + 0.035, the calibration curve was found to be linear in the aforementioned concentrations (the correlation coefficient (r2 ) of determination was 0.999) [Figure [Figure22 and and33]. Table 3 Validation parameters Figure 2 Calibration curve Figure 3 Overlay figure of linearity ranges of lafutidine (10�C50 ��g/ml) Precision Assay of method precision (intraday precision) was evaluated by carrying out six GSK-3 independent assays of test samples of lafutidine.