Simultaneous Determination of Metronidazole and Miconazole Nitrate in Pharmaceutical Formulations by RP-HPLC with Greener Solvent

The aim of this study was to develop a simple, sensitive, accurate, efficient, and reproducible Reverse-Phase High-Performance Liquid Chromatography (RP-HPLC) method that maintains stability for the simultaneous determination of Miconazole nitrate and metronidazole in vaginal gel formulations. Using a diode array detector at 210 nm, chromatography was conducted on a Zorbax SB-8 column (150×4.6 mm, 3.5 μm) under linear elution with a combination of solvent A (water) and solvent B (isopropyl alcohol) as the mobile phase, including a flow rate of 1.0 mL/min. The linearity of metronidazole and Miconazole nitrate exhibited correlation coefficients of 0.9997 and 0.9995, respectively. The limits of detection and quantification were 0.05 μg/mL and 0.42 μg/mL for metronidazole, and 0.16 μg/mL and 1.24 μg/mL for Miconazole nitrate. The technique yielded good results, with recovery rates between 98.0% and 102.0% and repeatability of ≤2.0%. This method is suitable for routine quality control testing of dosage forms containing these compounds due to its straightforwardness, accuracy, and precision. The method's run time is reduced, leading to a lower solvent requirement. The analytical method was developed and validated to comply with ICH guidelines.