UV AND RP -HPLC METHOD DEVELOPMENT AND VALIDATION OF LEVOKETOCONAZOLE

Abstract

Objective: This study aimed to develop a precise and reliable method for the estimation of levoketoconazole in bulk drug and pharmaceutical dosage forms using UV-visible spectrophotometry and RP-HPLC. Method: UV-visible spectrophotometric determination was performed using an Elico double-beam SL 210 UV visible spectrophotometer with a deuterium lamp at λmax 296 nm using methanol as the medium. The UV visible spectrophotometric and HPLC methods were linear over concentration ranges of 50–250 µg/ml and 10 100 µg/ml, respectively. HPLC analysis was performed using a C18 column (1.7 micron) with a photodiode array detector and a quaternary pump at a flow rate of 1 ml/min. The run pressure was 2140 psi. Acetonitrile:water (20:80) was used as the mobile phase, and the effluent was monitored at 296 nm. Both methods were validated for linearity, precision, accuracy, robustness, ruggedness, detection and quantification limits, and formulation analysis according to ICH guidelines. Results: The retention time was 3.8 minutes, and the RSD for precision studies and recovery analysis of the UV and HPLC methods was less than 1%. The reported recovery values were 99.5–100.8% for HPLC and 70–86% for UV. Conclusion: Both methods were validated according to ICH guidelines. The developed methods were applied for the estimation of levoketoconazole in bulk drug and pharmaceutical dosage forms.