Xây dựng quy trình định lượng (S)-amlodipin bằng phương pháp HPLC sử dụng pha động có chứa tác nhân đối quang

Abstract

A high performance liquid chromatographic (HPLC) method was developed for chiral separation of amlodipine. The two existent enantiomers were separated on a Germini NXC18 column. The mobile phase was methanol-phosphate buffer (5 mmol. mLNaH₂PO₄, pH 2.5; containing 17.5 mM sulfobutylether-β-cyclodextrin (SBE-β-CD) and 0.3 mM polyethylene glycol-20000 (PEG)(75: 25, v/v): UV detection at 237 nm. The resolution of the 2 enantiomers was more than 1.5. The effective range of quantification for both enatiomers was 250 - 750 µg.mL⁻¹. Relative standard deviation was below 2% (n = 6), the recovery range was 98-102%. Thereby, the method proved suitable for quality control ofamlodipine materials and products.