Sustainable RP-HPLC method for rapid quantification of arformoterol: development, validation, and greenness assessment
摘要
The current research work aimed to establish a sustainable and eco-friendly RP-HPLC method for the separation and estimation of Arformoterol in bulk and dosage forms.
MethodThe optimized method efficiently separates Arformoterol using a C18 Kromasil (150 × 4.6 mm, 5 μm) column and a mobile phase of Acetonitrile: 0.01 N potassium dihydrogen phosphate (pH 4.8) in a 40:60 v/v ratio with a flow rate of 1 mL/min. The eluted Arformoterol from the column was detected with a PDA detector at 228 nm. A temperature of 30 ± 2 °C was maintained in both the column oven and the sample injection system. The Green analytical chemistry tools, such as Analytical eco scale, analytical greenness, and green analytical procedure index, were used to assess the extent of greenness of the method to determine the sustainability of the method by eco-friendly nature.
ResultArformoterol was successfully eluted at 2.330 min, accompanied by a high number of theoretical plates, indicating efficient column performance. The method demonstrated excellent linearity (0.75 µg/mL to 4.5 µg/mL) with a regression coefficient of 0.999. The limits of detection and quantification were assessed to be 0.15 µg/mL and 0.46 µg/mL, respectively, confirming the method’s sensitivity. The other validation parameters, such as accuracy, precision, and robustness, offered by the developed RP-HPLC method were in accordance with ICH guidelines. Additionally, forced degradation studies ensure the method’s stability-indicating ability by identifying the percentage degradation of Arformoterol. The method demonstrates excellent environmental sustainability with an Eco-Scale score of 81, a green analytical procedure index with a balanced range, and an analytical greenness AGREE score of 0.70.
ConclusionThe developed chromatographic method is highly effective in separating Arformoterol with an environmentally friendly nature.
Graphical abstract