Determination of Seven Elemental Impurities in Vonoprazan Fumarate Tablets and Its Raw Materials by Inductively Coupled Plasma-Mass Spectrometry
Objective To establish an inductively coupled plasma-mass spectrometry(ICP-MS)method for the determination of seven elemental impurities in Vonoprazan Fumarate Tablets and its raw materials.Methods The plasma power was 1 550 W,the plasma gas was argon with a flow rate of 14 L/min,the carrier gas was argon with a flow rate of 4.9 mL/min,the rotation rate of peristaltic pump was 40 r/min,the kinetic energy discrimination(KED)determination mode and full-quantitative analysis acquisition mode were adopted.Results The linear ranges of arsenic,cadmium,mercury,lead,cobalt,nickel,and vanadium were 0-30ng/mL,0-12ng/mL,0-60ng/mL,0-12ng/mL,0-120ng/mL,0-120ng/mL,0-120ng/mL(r>0.990).The limit of detection(LOD)was in the range of 0.002-0.052 ng/mL,the limit of quantification(LOQ)was in the range of 0.006-0.159 ng/mL.The RSDs of precision and repeatability tests were lower than 10.0% .The average recovery rate of the above elements was in the range of 97.46%-102.11% with the RSD of 0.49%-4.11% (n=9).Only cadmium,mercury,lead,and nickel were detected in three batches of finished products,with contents of 0.05 mg/kg,0.24-0.35 mg/kg,0.04-0.16 mg/kg,and 0.41-0.49 mg/kg,respectively.Only mercury,nickel,and vanadium were detected in three batches of raw materials,with contents of 0.09-0.64 mg/kg,0.28-0.38 mg/kg,and 0.01-0.03 mg/kg,respectively.Conclusion The established method is simple,fast,sensitive,accurate,and precise,which can be used for content control of the elemental impurities in Vonoprazan Fumarate Tablets and raw materials.
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