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@article{205997,
        author = {Burra Lekhya and G Srinivasa Rao and Guduru Rajeswari and kolavali yalla reddy},
        title = {HPLC METHOD FOR SIMULTANEOUS DETERMINATION OF AMBROXIL AND CEFADROXIL IN PHARMACEUTICAL DOSAGE FORM},
        journal = {International Journal of Innovative Research in Technology},
        year = {2026},
        volume = {13},
        number = {1},
        pages = {9103-9115},
        issn = {2349-6002},
        url = {https://ijirt.org/article?manuscript=205997},
        abstract = {Background: A simple, rapid, and cost-effective Reversed-Phase High-Performance Liquid Chromatographic (RP-HPLC) method was developed and validated for the simultaneous estimation of Cefpodoxime proxetil and Ambroxol HCl in combined commercial pharmaceutical dosage forms.
Methods: Chromatographic separation was achieved on a Symmetry C18 column (150 \times 4.6mm, 5 µu maintained at ambient temperature. The optimized mobile phase consisted of a pH 3.5 phosphate buffer and acetonitrile in a ratio of 30:70 (v/v), pumped isocratically at a flow rate of 1.0\mL/min. Isopiestic UV detection was performed at a wavelength of 254nm. The method was thoroughly validated in accordance with the International Council for Harmonisation (ICH) guidelines. Results: The retention times for Cefpodoxime proxetil and Ambroxol HCl were found to be 2.162min and 3.305\min, respectively, yielding a total analysis runtime of under 5 minutes. The calibration curves demonstrated excellent linearity (R2 = 0.999 for both analytes) over the concentration ranges of 20–100µu/g/mL for Cefpodoxime proxetil and 12–60 µu/g/mL for Ambroxol HCl. The method proved highly accurate, with mean recovery percentages of 100.0% and 100.3%, and exceptionally precise, with system precision % RSD values of 1.6% and 0.5% for Cefpodoxime proxetil and Ambroxol HCl, respectively. The limits of detection (LOD) were 0.2µu/g/mL and 1.0 \ µu g/mL, while the limits of quantitation (LOQ) were 0.5µu\g/mL and 1.2\ µu\g/mL, respectively. Robustness studies confirmed that minor operational variations did not significantly impact the method's reliability.
Conclusion: The validation metrics statistically prove that the proposed RP-HPLC method is specific, accurate, precise, and rugged. Due to its short analysis time and lack of baseline interference from common excipients, this method is highly suitable for routine batch analysis and quality control of pharmaceutical formulations containing this dual-drug combination.},
        keywords = {RP-HPLC, Cefpodoxime proxetil, Ambroxol HCl, Method Validation, Quality Control, ICH Guidelines.},
        month = {June},
        }