ISO 23190-2021 pdf download.Traditional Chinese medicine 一 Determination of aristolochic acids in natural products by high-performance liquid chromatography (HPLC).
7 Apparatus
Use the usual laboratory apparatus and, in particular, the following.
7.1 HPLC, consisting of a high-pressure infusion pump, sampler and chromatographic column, DAD,
integrator or data processing system.
7.2 Glassware. All glassware shall be thoroughly cleaned before use.
7.3 Grinder, used to smash the raw herbal materials.
7.4 Volumetric flasks, with a capacity of 2,0 ml and 10,0 ml.
7.5 Conical flask, with a capacity of 100 ml and a glass stopper.
8 Test method
8.1 General principle
The HPLC-DAD method is applied to detect the presence of aristolochic acid I. The parameters can vary depending on the particular condition of different instruments. The procedures of the HPLC-DAD method can be modified if the accuracy and precision are validated, such as a new analysis method with the same or higher accuracy and precision.
8.2 Caution and safety considerations
Due to the toxicity of aristolochic acid I, necessary precautions shall be taken in all operations. The solutions and the apparatus used in the test should not pollute the environment.
8.3 Stock solution of standard
Dissolve 2 mg of aristolochic acid I in methanol or 80 % methanol and store at 4 °C.
8.4 HPLC condition
8.4.1 Chromatographic system and system suitability
a) Column
Stationary phase: octadecylsilyl bonded silica gel as chromatography column or equivalent.
b) Mobile phase
— Mobile phase A: acetonitrile.
Mobile phase 8: 0,05 % phosphoric acid solution
c) Wavelength of the detector: 254 nm.
d) The ultraviolet absorption (UV) spectrum of aristolochic acid lis shown in Figure 2.ISO 23190 pdf download.