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Microwave-assisted digestion using nitric acid for heavy metals and sulfated ash testing in active pharmaceutical ingredients

机译:微波消解,使用硝酸进行重金属和活性药物成分中硫酸盐灰分测试

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摘要

The monitoring of inorganic impurities in active pharmaceutical ingredients plays a crucial role in the quality control of the pharmaceutical production. The heavy metals and residue on ignition/sulfated ash methods employing microwave-assisted digestion with concentrated nitric acid have been demonstrated as alternatives to inappropriate compendial methods recommended in United States Pharmacopoeia (USP) and European Pharmacopoeia (Ph. Eur.). The recoveries using the heavy metals method ranged between 89 % and 122 % for nearly all USP and Ph. Eur. restricted elements as well as the recoveries of sodium sulfate spikes were around 100 % in all tested matrices. The proposed microwave-assisted digestion method allowed simultaneous decomposition of 15 different active pharmaceutical ingredients with sample weigh up to 1 g. The heavy metals and sulfated ash procedures were successfully applied to the determination of heavy metals and residue on ignition/sulfated ash content in mycophenolate mofetil, nicergoline and silymarin.
机译:活性药物成分中无机杂质的监测在药物生产的质量控制中起着至关重要的作用。在美国药典(USP)和欧洲药典(Ph。Eur。)中,已证明采用微波辅助消化的浓硝酸中的重金属和燃烧/硫酸灰分法残留物可作为不适当药典方法的替代方法。对于几乎所有的USP和Ph.Eur,使用重金属方法的回收率在89%和122%之间。所有测试基质中的限制性元素以及硫酸钠加标的回收率均约为100%。拟议的微波辅助消化方法可同时分解15种不同的活性药物成分,样品重量可达1 g。重金属和硫酸盐灰分方法已成功地用于测定麦考酚酯,麦角苦参碱和水飞蓟素中重金属和残留物的着火/硫酸盐灰分含量。

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