The invention discloses a method for detecting related substances of trazodone
hydrochloride sustained release tablets, and belongs to the technical field of pharmaceutical analysis. According to the detection method,
high performance liquid chromatography is adopted, and the chromatographic condition is that an octadecyl bonded
silica gel column is used as a
chromatographic column; the
column temperature is 25-35 DEG C, and the flow velocity is 0.8-1.2 ml / min; the sample size is 5-15 [mu] l, and the detection
wavelength is 252-256 nm; the mobile phase A is a
potassium hexafluorophosphate buffer solution; the mobile phase B is
acetonitrile; and carrying out
gradient elution. Compared with trazodone
hydrochloride sustained-release tablet imported
drug registration standards and United States
Pharmacopoeia related substance detection methods of trazodone
hydrochloride bulk drugs, the method abandons a tailing-sweeping agent
triethylamine suitable for an alkaline sample, adjusts the pH value of a mobile phase to be acidic, improves the peak shape and increases retention of trazodone hydrochloride and impurities through a
chaotropic agent potassium hexafluorophosphate buffer solution, and improves the quality of trazodone hydrochloride sustained-release tablets. The method has the advantages of moderate
impurity retention, good separation effect, excellent peak shape, long service life of the
chromatographic column and reduction of the analysis cost. The method has the advantages of strong specificity, high sensitivity, high accuracy and good durability.