Cefpodoxime proxetil, a third-generation cephalosporin and ambroxol hydrochloride, a mucolytic agent, are frequently co-formulated for the treatment of respiratory tract infections, necessitating reliable analytical methods for simultaneous estimation in pharmaceutical dosage forms. A robust and accurate reversed-phase high-performance liquid chromatography (RP-HPLC) method was developed and validated for the quantification of these drugs in combined formulations in accordance with ICH Q2(R1) guidelines. Chromatographic separation was achieved using a Phenomenex C18 column with a mobile phase of methanol and phosphate buffer (pH 4.5) in a 70:30 (v/v) ratio, at a flow rate of 1.0 mL/min, with detection carried out at 254 nm. Validation parameters assessed included specificity, linearity, precision, accuracy, sensitivity, robustness and system suitability. The method demonstrated excellent linearity in the concentration ranges of 50–150 µg/mL for cefpodoxime proxetil and 30–90 µg/mL for ambroxol hydrochloride, with correlation coefficients (R²) greater than 0.999 for both analytes. Accuracy studies yielded mean recoveries within 98–102%, while precision results confirmed reproducibility with %RSD values below 2%. Limits of detection and quantitation confirmed the sensitivity of the method and deliberate variations in chromatographic conditions verified robustness. All system suitability parameters met acceptance criteria, further establishing the reliability of the method. The proposed RP-HPLC method is simple, rapid, precise, accurate and stability-indicating, making it highly suitable for routine quality control, batch release testing and regulatory submissions of cefpodoxime proxetil and ambroxol hydrochloride in combined pharmaceutical dosage forms.
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