Eco-friendly RP-HPLC determination of bambuterol hydrochloride and montelukast sodium in tablet dosage with dissolution analysis
Manal Ibrahim, Nesrin K. Ramadan, Magda M. Ibrahim, Shereen A. Boltia
TL;DR
This paper presents a greener and validated HPLC method for determining two drugs in tablets, with a focus on reducing solvent hazards.
Contribution
A novel eco-friendly RP-HPLC method with reduced solvent hazard for simultaneous drug analysis in tablets.
Findings
The method showed linearity for bambuterol hydrochloride and montelukast sodium in specified concentration ranges.
Mean recoveries of 100.92% and 99.39% were achieved for the two drugs in tablet dosage forms.
The method demonstrated improved greenness and sustainability compared to existing procedures.
Abstract
A simple, eco-friendly, and precise isocratic RP-HPLC method was developed and validated for the simultaneous determination of bambuterol hydrochloride (BBL) and montelukast sodium (MTK). Separation was performed on an Inertsil C18 column (250 × 4.6 mm, 5 μm) using ethanol/0.025 M phosphate buffer (pH 3.0) at 70:30 (v/v) on an Agilent 1200 Infinity II system. The method complied with ICH criteria and showed linearity over 1.20–100.00 µg mL⁻¹ (BBL) and 5.00–100.00 µg mL⁻¹ (MTK). Application to a combined tablet dosage form yielded mean recoveries of 100.92 ± 1.08% (BBL) and 99.39 ± 1.41% (MTK). Dissolution profiling was performed in 900 mL of 0.5% sodium lauryl sulfate medium. Method greenness and sustainability were benchmarked against a reported procedure using multiple tools, Analytical Eco-Scale, MoGAPI, AGREE, RGB-12, D-CHEMS-1, GEAR, CaFRI, CACI, and BAGI demonstrating a safer…
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Taxonomy
TopicsAnalytical Methods in Pharmaceuticals · Analytical Chemistry and Chromatography · Pharmacological Effects and Assays