Determination of contents and related substances of felodipine and metoprolol tartrate in compound felodipine sustained-release tablets by HPLC / 中国药学杂志

ABSTRACT

OBJECTIVE: To establish an HPLC method for determining the contents and related substances of felodipine and metoprolol tartrate in compound felodipine sustained-release tablets. METHODS: The analysis of felodipine was performed on an Agilent Eclipse XDB-C18 column (4.6 mm × 150 mm, 5 μm), using a mobile phase of methanol-acetonitrile-water (502030) at the flow rate of 1.0 mL · min-1. The column temperature was maintained at 25℃. The detection wavelength was set at 238 nin and injection volume was 20 μL. The analysis of metoprolol tartrate was performed on an Agela Venusil MP C18 column (4.6 mm × 150 mm, 5 μm), using a mobile phase of 0.48% ammonium acetate (pH adjusted to 7.5 with triethylamine and glacial acetic acid)-acetonitrile-methanol (652015) at the flow rate of 1.0 mL · min-1. The column temperature was maintained at 30℃. The detection wavelength was set al 275 nm and injection volume was 20 μL. RESULTS The linear ranges of felodipine and metoprolol tartrate were 0.005-0.06 mg · mL-1 and 0.05-0.60 mg · mL-1, respectively. The average recoveries of felodipine and metoprolol tartrate were 100.70% and 99.62%, respectively. The RSDs of this method were all less than 2% (n=9). CONCLUSION: The method is applicable for the contents and related substances control of compound felodipine sustained-release tablets.