Abstract

DETERMINATION OF DANAZOL IN BULK AND PHARMACEUTICAL FORMULATION

K. Vijay Kumar*, K. Sujatha and Dr. Arumugam Yasodha

ABSTRACT

A new, simple, rapid, precise, accurate and reproducible RP-HPLC method for estimation of Danazol in bulk form and marketed formulation. Separation of Danazol was successfully achieved on a Phenomenex Luna C18 (4.6×150mm, 5µm) column in an isocratic mode of separation utilizing Acetonitrile and Tris Hcl buffer pH (50:50%v/v)at a flow rate of 0.9 mL/min and the detection was carried out at 270nm. The method was validated according to ICH guidelines for linearity, sensitivity, accuracy, precision, specificity and robustness. The response was found to be linear in the drug concentration range of 20-100mcg/mL for Danazol. The correlation coefficient was found to be 0.9982 for Danazol. The LOD and LOQ for Danazol were found to be 4.4µg/mL and 13.3µg/mL respectively. The proposed method was found to be good percentage recovery for Danazol, which indicates that the proposed method is highly accurate. The specificity of the method shows good correlation between retention times of standard solution with the sample solution. Therefore, the proposed method specifically determines the analyte in the sample without interference from excipients of Pharmaceutical dosage forms.

Keywords: Danazol, RP-HPLC, Accuracy, Precision, Robustness, ICH Guidelines.