Development And Validation Of Rp-Hplc Method For Determination Of Rifapentine And Moxifloxacin Hydrochloride In Bulk And Tablet Dosage Form

Abstract

A novel, simple, precise, and accurate reverse-phase high-performance liquid chromatography (RP-HPLC) method was developed and validated for the simultaneous determination of Moxifloxacine hydrochloride and Rifapentine in bulk and pharmaceutical formulation. The assay involves the elution of Moxifloxacine hydrochloride and Rifapentine on Qualisil BDS C₁₈ column (250 mm x 4.6 mm, 5 μ) using mobile phase composition of methanol: sodium phosphate dihydrate buffer with pH adjusted to 3 in the ratio of 70:30 (v/v). The wavelength of detection was 270 nm. The retention time of Moxifloxacine hydrochloride and Rifapentine were found to be 3.66 and 7.35 minutes respectively at a 1.0 ml/min flow rate. Linearity was studied in the concentration range of 4-24 μg per mL and 10-60 μg per mL for rifapentine and Moxifloxacine hydrochloride respectively, with a correlation coefficient of 0.999 and 0.998. The proposed method can be used for routine quality control in bulk and tablet dosage forms. The newly developed method was validated according to ICH guidelines with respect to linearity, recovery, precision, ruggedness, robustness, and sensitivity.