Xây dựng và thẩm định phương pháp định lượng đồng thời carbocistein và chất salbutamol trong nước viên nang cứng bằng phương pháp HPLC

Abstract

Several pharmaceutical products combining salbutamol and carbocisteine are currently available on the market; however, current pharmacopoeias such as USP 2025 and BP 2025 have not yet included any monograph for this finished combination product. Moreover, the content of carbocisteine is 250-fold higher than that of salbutamol, which poses a significant challenge for the development of a simultaneous assay method. To enhance drug quality control, this study focused on the development and validation of a simple and robust HPLC method for simultaneous determination of salbutamol sulfate and carbocisteine in capsule formulations. Chromatographic separation was achieved using a C18 column (150 × 4.6 mm, 5 µm), with detection at 225 nm, a flow rate of 1.2 mL/min, an injection volume of 50 µL, and a mobile phase consisting of 0.1% (v/v) trifluoroacetic acid and acetonitrile with a gradient elution program. The method was fully validated for specificity; linearity with a range of 300 – 700 µg/mL for carbocisteine and 1.2 – 2.8 µg/mL for salbutamol, with correlation coefficients R = 1.000 and intercept percentages less than 1.0%; precision with RSD (%) of 0.5% for carbocisteine and 1.1% for salbutamol; and recovery at three concentration levels for both carbocisteine and salbutamol within the range of 98% – 102%.