Abstract

ANALYTICAL METHOD DEVELOPMENT AND VALIDATION STUDIES OF DRUG IN PHARMACEUTICAL DOSAGE FORM

Sanket V. Oak*, Vaishali Jadhav, Neha Margaj, Kalyani Pawar, Trunali Ghude, Ashish S. Jain

ABSTRACT

The aim of the present study was to develop and validate a stability indicating reverse phase high performance liquid chromatography (RP-HPLC) method for estimation of Itraconazole in bulk and capsule dosage form. The chromatographic separation was performed on a peerless basic C-18 column (250 4.6 mm, i.d, 5μm) at a flow rate of 1 mL per minute. The mobile phase employed was Acetonitrile: Water (85:15% v/v). The column temperature was maintained at 30°C, and 10μl of sample were injected. The detection wavelength was 263 nm. The developed RP-HPLC method was validated in accordance with ICH guidelines. Itraconazole had retention time of 3.7 minutes. Linearity was observed in the 10-60 g/ml. Itraconazole had detection limits of 0.438Itraconazole had quantitation limits of 1.328respectively. The percent recovery for Itraconazole is 99.78 percent, respectively. In the presence of acidic and basic conditions, no major degradation was observed. Peak area decreased under oxidative stress conditions. The proposed RP-HPLC method can be used as a stability indicating method for the assay of Itraconazole in bulk and capsule dosage form.

Keywords: Itraconazole, capsule dosage form, RP-HPLC, stability indicating method, stress degradation and validation.