Improvement of Determination Method of Acarbose Tablets by High-Performance Liquid Chromatography with Diode Array Detector / 中国药学杂志

ABSTRACT

OBJECTIVE: To develop an high-performance liquid chromatography (HPLC) method with diode array detector (DAD) for determination of acarbose in acarbose tablets. METHODS: An Alltima C18 column (4.6 mm×250 mm, 5 μm) was used for the separation, with acetonitrile-10 mmol·L-1 ammonium dihydrogen phosphate (containing 0.04% sodium 1-octanesulfonate, adjusted pH to 3.3 with H3PO4) (15∶85) as the mobile phase at the flow rate of 0.8 mL·min-1. The detection wavelength was set at 200 nm and the column temperature was maintained at 30℃. RESULTS: The method showed good linearity with a correlation coefficients (r) of 1.000 0. The specificity study demonstrated satisfactory resolutions between acarbose, other ingredients in the drug and forced degradation products. The precision and stability were satisfactory with the relative standard deviations (RSDs) of 0.088% and 0.22%, respectively. The average spiked recovery was 98.49% with RSD of 0.24% (n=9). The content of acarbose in four batches of acarbose tablets was 51.69, 51.75, 51.72 and 51.62 mg·tablet-1, respectively. CONCLUSION: The established method is accurate, simple and rapid, and can be utilized for determination of acarbose in acarbose tablets.