An antibiotic drug used to treat various bacterial infections such as skin, stomach, liver, joints, brain, vagina, spinal cord, lungs, heart or bloodstream. Different formulations like tablets, capsules, injections, creams, and ointments are available as commercial products. A concise, accurate, and reliable isocratic reverse-phase high-performance liquid chromatographic (RP-HPLC) method was designed to determine metronidazole drug substance in finished dosage forms quantitatively. This route ensures a shorter run time for elution while attaining consistent retention time for accurate results. This study developed a greener approach using Isopropyl alcohol (IPA) as a solvent.
This study employs a simple, specific, linear, accurate, and precise reverse-phase liquid chromatographic method to quantify Metronidazole's main component and assess the metronidazole-related process and degradation impurities in finished drug formulation. The Chromatographic separation was accomplished using a Water Symmetry C18 column with 100 mm x 4.6 mm dimensions and a particle size of 3.5 μm. The mobile phase, consisting of Isopropyl alcohol and water (20:80 v/v), was employed at a 1.000 ml/min flow rate with an injection volume of 10 μl. The column oven temperature was set at 30 °C, while the autosampler temperature was maintained at 25 °C. Wavelength detection was configured at 315 nm, resulting in a retention time of approximately 2.4 min for metronidazole.
Similarly, to quantify the organic impurities, the same chromatographic conditions were used in the related substances method except for altering the column using the Zorbax, SB, C8 with dimensions of 150 mm x 4.6 mm and a particle size of 3.5 μm.
In this report greener approach was implemented to develop a promising method that will reduce the difficulties associated with other reported methods similar to tedious in use, less sensitive, costly, etc. As the run time of the method is reduced, the solvent requirement is also reduced making the method greener. Further, this method was employed to assess the force degradation of metronidazole FPs. which demonstrated metronidazole Impurity-A and unspecified impurities were accurately quantified under several ICH-recommended stress conditions like hydrolytic, oxidation, and thermal.