Objective: To establish an HPLC method for the determination of the related substances in telmisartan. Methods: Waters Symmetry Shield RP8 (150 mm×4.6 mm, 3.5 μm) column was adopted. The mobile phase A was 0.1% phosphoric acid solution (pH was adjusted to 3.0 with triethylamine), and the mobile phase B was acetonitrile. The gradient elution was performed. The flow rate, column temperature and wavelength were 0.8 mL·min-1, 25 ℃ and 230 nm, respectively. Results: The resolutions between the peaks of telmisartan and nine known impurities were greater than 1.5. The limits of quantitation of all impurities were less than 40 ng·mL-1, and the limits of detection of all impurities were less than 10 ng·mL-1. The standard curves of telmisartan and its impurities were linear within the range 30-600 ng·mL-1, and the correlation coefficients were all greater than 0.999 5. The average recovery rates of impurities Ⅰ-Ⅸ were 93.8%, 99.8%, 97.5%, 99.2%, 99.8%, 98.3%, 98.4%, 99.2% and 99.7%, respectively, and the RSDs of 9 results were all less than 2.0%. Changing the flow rate, column temperature, wavelength, mobile phase ratio and pH did not affect the detection results of the related substances. The results of maximum single impurity were 0.02% in three batches of telmisartan, and the results of total impurities were less than 0.10%. Conclusion: The method is highly specific, sensitive, precise and accurate, and can be used for the determination of related substances of telmisartan.
WANG Chun, ZHANG Su-zhen, TAO Hong-zhu, PENG Ya, ZHAO Bin-feng
. Determination of related substances in telmisartan by HPLC[J]. Chinese Journal of Pharmaceutical Analysis, 2024
, 44(1)
: 126
-133
.
DOI: 10.16155/j.0254-1793.2024.01.13
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