A New Stability Indicating Ultra Performance Liquid Chromatography-PDA Method for the Estimation of Valganciclovir in Bulk 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 150μg/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 2.827μg/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.