Swift and Precise Determination of Rifampicin by RP-HPLC Technology Development in Pharmaceuticals

Abstract

Rifampicin (RIF) is a first-line antituberculous agent that binds with polymerase subunit and inhibits bacterial DNA-dependent RNA polymerase, permitting direct blocking of the elongating RNA. The study aimed to develop a better, more precise, and easy reversed-phase HPLC process that used readily available, less expensive chemicals and materials in an isocratic mode. The method guarantees that accuracy, precision, robustness, and other requirements are fulfilled and satisfied as specified by the ICH or FDA rules. According to the ICH recommendations, analytical characteristics including linearity, accuracy, specificity precision, detection limit, and quantification limit were determined. Rifampicin was separated chromatographically using the mobile phase combination, acetonitrile, and methanol (80:20 v/v) with a C-8 column at the speed of 1.7 mL/min in both pumps with a continuous run time of up to 2 min. The recovery of RIF extended from 98.9 to 100.8 with a relative standard deviation (% RSD) of about 1.5%. A stability investigation study showed that the drugs were stable for a long enough period of time. The limit of measurement for RIF was found to be 10 µg/mL. The average recovery rate was obtained at 98.96%. The study supported the retention times of the analytes, and the chromatographic runs were accurate and free of interfering peaks. This method of analysis is useful in pharmacokinetics and bioequivalence studies.