Scholars Research Library

Scholars Research Library

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Der Pharmacia Lettre

Abstract

Development and validation of a stability indicating uplc method for determination of Voriconazole in pharmaceutical formulation

Author(s): G. Naveen Kumar Reddy, V. V. S. Rajendra Prasad, N. Devanna, Prashant Kumar Maharana

Simple, rapid, sensitive, accurate, robust & rugged stability indicating analytical method for determination of voriconazole in pharmaceutical formulations is developed and validated by using UPLC & applied the developed and validated method for determining the assay of voriconazole in tablets (Vfend®), as there is no official monograph & no analytical method by UPLC. Chromatography was performed with mobile phase containing sodium dihydrogen ortho phosphate & acetonitrile in the ratio of 50:50,adjusted to pH 5.50±0.05 with dilute NaOH, with a flow rate of 0.5mL/min, C-18 column & UV detection at 254nm.The method was validated for linearity, accuracy, ruggedness, robustness, precision & bench top stability of sample & standard solution. Voriconazole tablets were subjected to different stress conditions like acid, alkali, peroxide, thermal, water & UV studies and checked for its specificity, degradation &stability. The developed method was very rapid with a run time of 1 min, accurate, robust, rugged and stable.


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