Aim: Simple, precise and accurate UV-spectrophotometric methods for estimation of Dapagliflozin were developed and validated as per ICH guidelines. Experimental and Results: These methods includes Calibration curve, Area under curve (AUC), First and Second order derivative method based on measurement of absorbance at a selected wavelengths using UV-visible spectrophotometer with 1 cm matched quartz cell and methanol with water as a solvent. All developed methods obeyed Beer's-lambert's law in the concentration range of 5-40 μg/mL, with correlation coefficient value less than 1. The percent amount of drug estimated by these methods was nearly 100%, found to be in good agreement with label claim of marketed tablet formulation. The recovery study was carried out at five different levels and results were found to be satisfactory. Conclusion: The results of estimation and validation parameters like accuracy, precision, ruggedness, linearity and range were studied for all the developed methods and were found to be within limits. The proposed method can be adopted for routine quality control for estimation of drug in formulation.
A simple, specific, accurate, precise and reproducible method has been developed and validated for the simultaneous estimation of hydrochlorothiazide and olmesartan medoxomil in combined dosage form by UV spectrophotometric method. UV spectrophotometric method includes simultaneous equation method (Method I) 271.5 nm and 257.0 nm λ max of both the drugs were selected, absorbance Ratio method (Method II) 261.5 nm an isoabsorptive wavelength and 257.0 nm were selected for estimation of hydrochlorothiazide and olmesartan medoxomil respectively and Three wavelength method (Method III), two wavelengths were selected such that hydrochlorothiazide give same absorbances (263.8 and 278.4 nm) at two selected wavelength while third wavelength (316.5 nm) was such that olmesartan gives nearly zero absorbance. The two drugs follow Beer's law over the concentration range of 5-25 µg/mL. The % recoveries of the both the drugs were found to be nearly 100 % representing the accuracy of the proposed methods. Validation of the proposed methods was carried out for its accuracy, precision, specificity and ruggedness according to ICH guidelines. The proposed methods can be successfully applied in routine work for the determination of hydrochlorothiazide and olmesartan medoximil in combined dosage form.
Objective: A simple, precise and accurate UV-spectrophotometric method is developed and statistically validated for estimation of Testosterone in gel formulation. The proposed method includes using regression equation, area under curve (AUC), first order derivative and second order derivative spectroscopic method.Methods: based on measurement of absorbance at a selected wavelength using UV-visible spectrophotometer with 1cm matched quartz cell and acetonitrile as a solvent. All developed methods obeyed Beer's-lambert's law in the concentration range of 5-25μg/mL, with correlation coefficient value less than 1.
Results:The percent amount of drug estimated was nearly 100%, found to be a good agreement with label claim of marketed gel formulation. The recovery study was carried out at three different levels, the validation study data was found to be statistically significant as all the statistical parameters are within the acceptance range (% RSD <2.0 and S.D. <±2.0).
Conclusions:The results of estimation and validation parameters like accuracy, precision, ruggedness, linearity and range were studied for all the developed methods and were found to be within limits. The results obtained were statistically compared using paired t-test and one way ANOVA analysis. The proposed method can be adopted for routine quality control for estimation of drug in formulation.
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