Chitosan Loaded Mucoadhesive Microspheres of Gliclazide - Journal

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dioxide, hypromellose, polyethylene glycol 400, polysorbate 80, and iron oxide red (used only in 1mg tablets)]. All the solutions were scanned in the range of 400-200 nm and checked for change in absorbance at respective wavelengths. In a separate study, drug concentration of 10 μg / ml was prepared independently from pure drug stock and commercial sample stock in selected media and analysed (N = 5). Paired t-test at 95% level was performed to compare the means of absorbance (Table 1). Accuracy As a part of determining accuracy of the proposed methods, different levels of drug concentrations (LQC, MQC and HQC) were prepared from independent stock solution and analysed (N=6). Accuracy was assessed as the standard deviation and percentage relative standard deviation studies were found to be satisfactory (Table 2). To give additional support to accuracy of the developed assay method, standard addition method was done. The percent recovery of the added pure drug was calculated as, % Recovery = [(C - C ) / C ] X 100 v u a Malipatil S.M et al./ Validated UV-Spectrophotometric Estimation of Entecavir in Bulk and Formulations Where C is the total drug concentration measured after v standard addition C is the drug concentration in the formulation u C is the drug concentration added to the formulation (Table a 4). Precision Repeatability was determined by using different levels of drug concentrations (same concentration levels taken in accuracy study), prepared from independent stock solution and analysed (N=6) (Table 2). Inter-day and intra-day variation and instrument variation were taken to determine intermediate precision of the proposed methods (N=6). The % relative standard deviation of the predicted concentrations from the regression equation was taken as precision (Table 3). Linearity To establish linearity of the proposed method, nine separate series of solutions of the drug (2-18μg / ml) were prepared from the stock solution and analysed. Limit Of Detection (LOD) and Limit Of Quantitation (LOQ) The LOD and LOQ of the Entecavir by proposed methods were determined by using calibration standards. LOD and LOQ were calculated as 3.3σ/S and 10σ/S, respectively, where S is the slope of the calibration curve and σ is standard deviation of the y-intercept of regression equation (Table 1). Table 4: Results of standard addition method Method Concentration Concentration % level of Total % Analytical of drug in of pure drug pure drug concentration of recovery ± SD formulation added (µg/ml) added drug found (µg/ml) (µg/ml) Method A 10 8 80 17.98 99.75 ± 0.01 10 10 100 20.12 101.20 ± 0.15 10 12 120 22.24 102.00 ± 0.01 Method B 10 8 80 18.02 100.25 ± 0.01 10 10 100 19.90 99.90 ± 0.52 10 12 120 21.88 99.00 ± 0.08 Method C 10 8 80 18.10 101.25 ± 0.12 10 10 100 20.21 102.10 ± 0.10 10 12 120 22.27 102.25 ± 0.03 (Each value is a result of three separate determinations) Table 5: Application of the proposed spectrophotometric methods for the determination of Entecavir in tablet dosage forms Method A Method B Method C Commercial products Amount Assay Amount Assay Amount Assay found (mg) (%) found (mg) (%) found (mg) (%) Entehep (0.5 mg) 0.498 99.6 0.501 100.2 0.502 100.4 Baraclude (0.5 mg) 0.499 99.8 0.502 100.4 0.503 100.6 Entehep (1.0 mg) 0.996 99.6 0.997 99.7 0.998 99.8 Baraclude (1.0 mg) 0.998 99.8 0.999 99.9 0.997 99.7 114 RJPS, Jul - Sep, 2011/ Vol 1/ Issue 2
Robustness: Robustness of the proposed method was determined by stability of the Entecavir at room temperature for 8 hours. Three different concentrations (LQC, MQC and HQC) were prepared in double distilled water. Mean percentage recovery was determined (Table 1). RESULTS AND DISCUSSION Malipatil S.M et al./ Validated UV-Spectrophotometric Estimation of Entecavir in Bulk and Formulations Fig 2 Graph I Fig 3 Graph 2 Fig 4 Graph 3 The methods discussed in the present work provide a convenient and accurate way for the analysis of Entecavir in 115 its pharmaceutical dosage form. Absorbance maxima of Entecavir at 253.6 nm (Method A) and in the first order derivative spectra, sharp peak at 242.6 nm (Method B) were selected for the analysis. Method C was area under curve (AUC) and the wavelength range for quantitation was 248.0- 258.0 nm. Linearity for detector response was observed in the concentration range of 2-18 μg/ml for all three methods. Percentage label claim for Entecavir in tablet analysis, by all the three methods, was found to be in the range of 99.6% to 100.60% Standard deviation and correlation coefficient for
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