Background: The present research paper described about the optimization of various zero order and first order UV spectrophotometric method using different buffers. Validation study was performed to develop a simple, sensitive, rapid, accurate and economical Ultra Violet spectrophotometric method for the estimation of Valganciclovir. Methods: UV 1800 double beam UV Visible Spectrophotometer with a pair of 10mm path length matched quartz cells were used for the study. Method A (Water), Method B (phosphate buffer pH2), Method C (Phosphate buffer pH4) and Method D (phosphate buffer pH5) were developed for estimation of Valganciclovir by zero-order and first-order derivative. Results: Linearity was carried out in the concentration range of 5-60 µg/ml and the correlation coefficient were found to be 0.999. The percentage recoveries were found to be 98-102%. The relative standard deviation was found to be <2%. The LOD and LOQ were found to be 0.3241 µg/ml and 0.8227 µg/ml respectively. Conclusion: Hence, the methods were validated according to ICH guidelines and can be adopted for the routine analysis of Valganciclovir in pure and tablet dosage form.
Background: The present article described about the systemic development of ultra-performance liquid chromatography (UPLC) method for the quantitative determination of valganciclovir in bulk and dosage form. The subsequent validation and degradation study was also performed. Methods: The chromatographic Separation was achieved with an HSS (100x2.1 mm, 1.8m).column with an isocratic mobile phase containing a mixture of 0.01N potassium dihydrogen orthophosphate and acetonitrile (55:45 v/v). The flow rate of the mobile phase was 0.3 ml/min with a column temperature of 30°C and detection wavelength at 254 nm. The developed method was validated according to the ICH guidelines with respect to linearity, accuracy, precision, specificity, detection limits and robustness. Results: The precision of the results, stated as the %RSD was below 1.0%. The accuracy of the method demonstrated at three levels in the range of 50%, 100% and 150% of the specification limit. The calibration curve was linear over a concentration range from 25 to 150 μg/ml with a correlation coefficient of 0.9997. The recovery of valganciclovir was found to be in the range of 98 to 102%, whereas the detection limits were found to be 0.933 and 2.827 μg/ml. Forced degradation study was carried out under acidic, alkaline, oxidative, photolytic and thermal conditions to prove the stability-indicating ability of the developed UPLC method. Conclusion: The method is validated according to the ICH guidelines and it is applied successfully for the determination of valganciclovir in tablets.
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