A simple, accurate reversed-phase high-performance liquid chromatography (HPLC) method was developed and validated for simultaneous determination of gliclazide (GLZ) and fluoroquinolone antibacterial levofloxacin (LVO). The method was developed by using a stainless steel analytical column C18 (250 × 4.6 mm, 5 μm). The system was operated using a mobile phase consisting of methanol and phosphate buffer (pH 3.0) at a flow rate of 0.8 mL/min with ultraviolet (UV) detection at 228 nm wavelength. The proposed method was validated using ICH analytical method validation guidelines. Utilizing the HPLC technique, an assay was intended to determine in vitro effects of levofloxacin on sulphonyl urea based anti-diabetic drug gliclazide. The obtained results were further verified with UV spectrophotometric method. Availability of gliclazide was reduced in the presence of levofloxacin. These in vitro analyses confirmed that the co-administartion of gliclazide and levofloxacin may serve the foundation for designing further in vivo studies.
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Chhajed, S.S., Sonawnae, S.S., More, P.K. et al. HPLC Method Development, Validation and Application to Determining In-Vitro Effect of Levofloxacin on the Availability of Gliclazide. Pharm Chem J 57, 445–450 (2023). https://doi.org/10.1007/s11094-023-02903-3
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DOI: https://doi.org/10.1007/s11094-023-02903-3