Department of Pharmacy, People's Hospital of Xinjiang Uygur Autonomous Region, Urumqi, China.
Institute of Clinical Pharmacy, People's Hospital of Xinjiang Uygur Autonomous Region, Urumqi, China.
Biomed Chromatogr. 2021 Apr;35(4):e5022. doi: 10.1002/bmc.5022. Epub 2020 Dec 3.
This study has developed and validated a novel UPLC method to quantify lacosamide (LCM), oxcarbazepine (OXC), and lamotrigine (LTG) in children with epilepsy in Xinjiang, China. Phenytoin sodium was used as the internal standard. The mobile phase contained ammonium dihydrogen phosphate solution (10 mmol/L, pH = 4.0) and methanol (55:45, v/v). The flow rate, injection volume, column temperature, and detection wavelength were 0.2 mL/min, 2 μL, 30°C, and 240 nm, respectively. The method was linear within 0.5-40, 2.5-80, and 2.5-40 μg/mL for LCM, 10-hydroxycarbazepine (MHD), and LTG, respectively (r ≥ 0.998). The intra- and inter-day precision as measured by the relative standard deviation values was between 1.36 and 4.50, 0.54 and 1.91, and 0.58 and 1.56%. Recovery ranged from 96.58 to 106.22%. All serum samples could be maintained for up to 3 h at ambient temperature, 24 h at 4°C, 30 days at -30°C, and after successive freeze-thaw cycles (24 h per cycle) in the absence of significant degradation.
本研究在中国新疆建立并验证了一种超高效液相色谱法,用于定量检测癫痫患儿体内的拉科酰胺(LCM)、奥卡西平(OXC)和拉莫三嗪(LTG)。苯妥英钠被用作内标。流动相由磷酸二氢铵溶液(10mmol/L,pH=4.0)和甲醇(55:45,v/v)组成。流速、进样量、柱温、检测波长分别为 0.2mL/min、2μL、30°C 和 240nm。该方法在 0.5-40、2.5-80 和 2.5-40μg/mL 范围内对 LCM、10-羟基卡马西平(MHD)和 LTG 均呈线性(r≥0.998)。日内和日间精密度(以相对标准偏差表示)分别在 1.36-4.50%、0.54-1.91%和 0.58-1.56%之间。回收率在 96.58-106.22%之间。所有血清样本在室温下可稳定 3 小时,4°C 下可稳定 24 小时,-30°C 下可稳定 30 天,在无明显降解的情况下,经过 24 小时一个循环的反复冻融(24 小时一个循环)后仍可保持稳定。