Determination of Impurity Profile in Rifapentine

Abstract

Rifapentine is a semi-synthetic rifamycin antibiotic as same as structure to rifampin. Rifapentine is approved by the US FDA as a first-line drug for once or twice-weekly dosing in the treatment of TB. The developed method is validated as per the guidelines of International Conference on Harmonization (ICH). The chromatographic column of Thermo BDS-Hypersil C18 (250 X 4.6mm, 5μm) and the separation was achieved by gradient elution. Analytical trials were carried by in Waters Alliance 2695 with 2996 PDA detector consisting of a quaternary gradient solvent manager, sample manager and photo diode array detector. Thermo BDS-Hypersil C18 (250mm×4.6mm, 5μm) column at 25°C with a mobile phase containing a gradient mixture of sodium di-hydrogen orthophosphate and acetonitrile with a run time of 55 minutes at monitored wavelength of 254nm. The solubility of rifapentine in methanol, ethanol, acetone, chloroform, acetonitrile, and dichloromethane was measured at temperatures ranging from (278° to 323° K) under atmospheric pressure. The solubility of rifapentine in the above solvents increased in the following order: chloroform, methanol, dichloromethane, ethanol, acetone. The method is developed for identification and quantification of related impurities in the API. The drug has advantage of five time’s longer half-life than rifampicin and it is recommended for use in intermittent therapy. Literature survey reveals that only bio-analytical method has been developed for the estimation of Rifapentine in blood, plasma, serum etc.