Abstract

DEVELOPMENT AND VALIDATION OF AN RP-HPLC METHOD FOR THE DETERMINATION OF SECNIDAZOLE IN BULK AND TABLET DOSAGE FORM

Suresha D. N., Muthuraj M. S.*, Naveen Kumar G. S.*

ABSTRACT

Reliable analytical techniques are crucial for the quantitative determination of secnidazole, a benzimidazole antimicrobial drug used to treat trichomonas infections in pharmaceutical formulations. The goal of the current work was to create and validate a straightforward, accurate, and sensitive reverse-phase high-performance liquid chromatographic (RP-HPLC) method for measuring secnidazole in tablet and bulk medication dosage forms. A Water C-18 column (5 µm, 4.6 × 250 mm) with an isocratic mobile phase made of acetonitrile and water (60:40, v/v) at a flow rate of 1.0 mL/min was used to accomplish chromatographic separation. With an injection volume of 20 µL and a column temperature of 25°C, detection was performed at 310 nm. The method was validated according to ICH guidelines for specificity, linearity, precision, accuracy, robustness, limit of detection (LOD), and limit of quantification (LOQ). secnidazole showed a retention time of 3.372min. The method demonstrated excellent linearity over the range of 10–150%, with a correlation coefficient (R²) of 0.9985 and regression equation Y = 27749.313X − 5366.9355X. System and method precision showed %RSD values of 0.0604% and 0.1640%, respectively. Mean recoveries at 80%, 100%, and 120% levels were 99.3%, 99.5%, and 99.3.%, respectively. The LOD and LOQ were found to be 0.7497 and 2.272 µg/mL, respectively. The approach showed adequate robustness, specificity, and system appropriateness. The established RP-HPLC method is appropriate for regular quantitative analysis of secnidazole in bulk medication and pharmaceutical tablet dosage forms since it was found to be straightforward, precise, accurate, sensitive, robust, and free of major excipient interference.

Keywords: Secnidazole; Quantification; Validation; RP-HPLC; Antimicrobials.