Abstract

VALIDATED RP-HPLC METHOD FOR THE DETERMINATION OF CASPOFUNGIN IN BULK AND TABLET DOSAGE FORM

P. D. Chaithanya Sudha* and Prof. D. Gowri Sankar

ABSTRACT

A novel, simple and economic reverse phase high performance liquid chromatography (RP-HPLC) method has been developed for the estimation of Caspofungin in bulk and tablet dosage form with greater precision and accuracy. Separation was achieved on Zorbax SB C18 column (150X4.6mm i.d., 5μm) in isocratic mode using Triflouro acetic acid PH-3.0 buffer, Acetonitrile and Methanol in the ratio of 50:40:10 (v/v/v) as mobile phase, pumped in to the column at flow rate of 1.0 ml/min and the detection of eluent from the column was carried out using variable wavelength UV detector at 210 nm. The total run time was 30 min and the column was maintained at ambient temperature. The retention time of Caspofungin was 16.101 min. The standard curves were linear over the concentration range of 50 – 150 μg/ml with R2 0.999 and the LOD and LOQ values for Caspofungin were 0.04 μg/ml and 0.12 μg/ml, respectively. The percentage recovery was found to be 97.7 – 100.45%, the % RSD was found to be 0.43. The percentage amount of a marketed tablet formulation of Caspofungin was found to be 99.7%. The method was validated as per ICH guidelines. Validation studies demonstrated that the proposed RP-HPLC method is simple, specific, rapid, reliable and reproducible. Hence the proposed method can be applied for the routine quality control analysis of Caspofungin in bulk and tablet dosage forms.

Keywords: Caspofungin, RP-HPLC, Method Development, Validation, ICH guidelines.