The Estimation of Fidaxomicin in tablet dosage forms by RP-HPLC

ABOUT AUTHOR
A. Malli Babu¹, P. Janaki Pathi*², N. Appala Raju^3
1Analytical Department, Hospira Healthcare India Pvt Limited, Chennai, India
²Analytical Department, Vishnu Chemicals Limited, Hyderabad, India
³Dept. of Pharmaceutical Chemistry, Sultan-Ul-Uloom College of Pharmacy, Hyderabad-500 034, India

Abstract
A simple, precise, rapid and accurate reverse phase HPLC method was developed for the estimation of Fidaxomicin in tablet dosage form. An Inertsil ODS-3V analytical column (250 x 4.6 mm, 5 μm partical size) with mobile phase consisting of mixture of buffer 0.3M Potassium Dihydrogenphosphate in water and adjusted to pH 3.0 by ortho-phosphoric acid and acetonitrile in the gradient program was used. The flow rate was 1.0 mL/min and the effluents were monitored at 222 nm. The retention time was 13.1 min. The detector response was linear in the concentration of 5-50 mcg/mL. The respective linear regression equation being y=2228.4x-2227.3.  The limit of detection and limit of quantification was 0.01mcg/mL and 0.03mcg/mL respectively. The percentage assay of Fidaxomicin was 99.3 %. The method was validated by determining its accuracy, precision and linearity. The results of the study showed that the proposed RP-HPLC method is simple, rapid, precise and accurate, which is useful for the routine determination of Fidaxomicin in bulk drug and in its pharmaceutical tablet dosage form.
Keywords: Fidaxomicin, RP-HPLC and Tablets.