Abstract

DEVELOPMENT AND VALIDATION OF STABILITY INDICATING RP-HPLC METHOD FOR DETERMINATION OF VORICONAZOLE AND ITS RELATED SUBSTANCE IN PARENTERAL DOSAGE FORM

Nitika V. Arrawatia*, Dr. Chirag J. Patel and Dr. M. M. Patel

ABSTRACT

An Isocratic Reversed-Phase High Performance Liquid Chromatographic (RP-HPLC) method has been developed and validated for the determination of Voriconazole and its related substance in parenteral dosage form. The method is simple, accurate, precise and capable of separating known impurities and degradant impurities from Voriconazole. Chromatographic separation has been achieved on Inertsil C18 (250*4.6mm, 5μm) column, mobile phase consisting of Ammonium phosphate dibasic buffer (6.6 gm of Ammonium phosphate dibasic into 1000ml water, adjust pH 6.0 with dilute ortho phosphoric acid): Acetonitrile (55:45%w/v), delivered at flow rate of 1.0ml/min with detection wavelength at 256nm. The drug was subjected to stress condition such as Acid, Base and Oxidative. The Degradation product was well resolved from the main peak and its Impurities and the mass balance was found close to 100.5%. The procedure was validated for Linearity (Correlation Co-efficient = 0.9999), % Recovery was found within the range of 98.60- 105.9%. The percentage RSD for precision and accuracy of the method was found to be less than 5%. The method was found to be Robust. This method can be successfully employed for the quantitative analysis of Voriconazole in its parenteral dosage form.

Keywords: Voriconazole, RP-HPLC, Forced Degradation Study, Validation.