Abstract：Objective To establish a rapid screening method for the detection of indometacin in antirheumatic pain relieving healthy products. Methods The samples of different dosage forms were extracted with 4 ml of 0.4% sodium hydroxide solution, acidified and precipitated impurities with 2 ml of 3 mol/L sulfuric acid solution. The filtrate was added with 1 drop of 5% ferric chloride solution and 3% hydrogen peroxide solution for color reaction. The confirmation of samples by high performance liquid chromatography-tandem mass spectrometry (LC-MS) was performed on a CAPCELL PAK C18 MG Ⅲ(2.0 mm×150 mm, 5 μm) column, with gradient elution of 0.02 mol/L ammonium acetateacetonitrile, the flow rate was 0.2 ml/min, the column temperature was 35°C, the injection volume was 10 μl, and the detection was multiple reaction monitoring (MRM) in negative ion mode. Results A total of 112 batches of samples of different dosage forms (27 batches of tablets, 5 batches of granules, 61 batches of capsules and 19 batches of pills)were collected by chromogenic reaction method for rapid screening. Sixteen batches of positive samples were detected(capsule 15 batches, pill 1 batch), the detection limit of method was 0.25 mg/times, the rate of missed detection and error detection was 0%, and the correct rate was 100%. Conclusion Color reaction has strong specificity, low missed detection rate and low false detection rate, and high accuracy. It can be employed in the rapid screening detection of Indometacin in antirheumatic pain relieving health products.
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