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Abstract A straightforward, environmentally friendly, and precise isocratic RP-HPLC technique was developed and validated for simultaneous determination of bambuterol hydrochloride (BBL) and montelukast sodium (MTK). An Agilent chromatograph equipped with an Inertsil C18 column (250 × 4.6 mm, 5 µm) was utilized, and chromatographic separation was achieved using a mobile phase comprising ethanol and 0.025 M phosphate buffer at pH 3.0 in a 70:30 v/v ratio. The method, adhering to ICH requirements, was validated for linearity ranges of 1.00–100.00 µg/mL and 2.00–100.00 µg/mL for BBL and MTK, respectively. The validated method was successfully applied to quantify BBL and MTK in a pharmaceutical tablet dosage form, with mean recovery percentages of 100.92 ± 1.08 and 99.39 ± 1.41, respectively, indicating satisfactory accuracy. Dissolution patterns of the pharmaceutical tablet dosage form were studied in a 900 mL 0.5% sodium lauryl sulfate dissolution medium. Various assessment tools, including Analytical Eco-scale, GAPI, AGREE, RGB 12, and the green-specific model D-CHEMS-1, were employed to evaluate the health and safety hazards of the developed methods. The RP-HPLC method demonstrated sustainability, greenness, simplicity, and effectiveness, successfully determining both drugs in their dosage form and dissolution media.
Ibrahim et al. (Thu,) studied this question.