Abstract
DEVELOPMENT & VALIDATION OF STABILITY INDICATING UPLC METHOD FOR QUANTITATIVE ESTIMATION OF VORICONAZOLE AND ITS IMPURITIES IN DRUG SUBSTANCE

Rambabu Katta*, Ramasrinivas and G. N. Rao

ABSTRACT

Simple and sensitive RP-UPLC method for the separation and quantification of voriconazole and its impurities are described. Samples are analyzed by means of reverse phase (RP-UPLC) using an Acquity UPLC BEH Shield RP18 (2.1mm x 100mm, 1.7μ), and the mobile phase consists of two Channels A and B. Channel-A 0.05% TFA in water and Channel-B: 0.05% TFA in methanol. The flow rate is 0.2 ml/min. The column temperature was maintained at 30°C and sample temperature was maintained at ambient and wavelength fixed at 255nm UV-detection. It is found that the method of RP-UPLC with UV-detection system for the analysis of voriconazole impurities are straight forward and applied in qualitative and quantitative analysis. The developed UPLC method was validated with respect to specificity, precision, linearity, ruggedness and robustness. Validation study compared as per ICH guideline.

Keywords: UPLC, Voriconazole, Stability Indicating, Validation.


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