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目的建立大鼠唾液和血浆中罗通定浓度的HPLC测定方法 ,研究单次静脉注射后大鼠唾液及血浆中罗通定浓度的相关性。方法色谱柱为Diamonsil(R)C_(18)柱(250 mm×4.6 mm,5μm);流动相为甲醇:水(70:30,V/V);流速1.0 mL·min~(-1);柱温30℃;检测波长281 nm。测定唾液和血浆中的罗通定浓度,并对腮腺、颌下腺唾液浓度与对应血浆质量浓度进行Pearson相关分析。结果罗通定的唾液和血浆浓度在0.1～20.0 mg·L~(-1)和0.5～40.0 mg·L~(-1)内线性关系良好,在唾液和血浆中的最低定量限和相对回收率分别为0.1 mg·L~(-1)、100.97%～107.50%和0.5 mg·L~(-1)、98.30%～111.20%,日内、日间精密度(RSD)均<10%;静注给药后,腮腺和颌下腺唾液浓度与对应血浆浓度呈正相关,Pearson相关系数(R)分别为0.987(P<0.01)和0.985(P<0.01)。结论首次建立了同时适用于唾液和血浆中微量罗通定分析的HPLC方法 ;唾液和血浆中的罗通定浓度具有良好的相关性,在罗通定的药动学研究及临床药物浓度监测时可以考虑以唾液代替血浆样本进行分析。
Objective To establish a method for the determination of loratadine concentration in rat saliva and plasma and the correlation between the concentration of loratadine in rat saliva and plasma after a single intravenous injection. The column was Diamonsil (R) C 18 column (250 mm × 4.6 mm, 5 μm). The mobile phase consisted of methanol and water (70:30, V / V) Column temperature 30 ℃; detection wavelength 281 nm. The concentrations of lootidine in saliva and plasma were determined, and the salivary concentrations of parotid and submandibular glands and corresponding plasma concentrations were analyzed by Pearson correlation. Results The concentrations of saliva and plasma in Luo Tongding had a good linear relationship between 0.1 ~ 20.0 mg · L -1 and 0.5 ~ 40.0 mg · L -1, and the lowest limit of quantification and relative recovery in saliva and plasma The precision of RSD was less than 10% in the range of 0.1 mg · L -1, 100.97% -107.50%, 0.5 mg · L -1, 98.30% -111.20% After administration, the salivary concentrations in the parotid and submandibular glands were positively correlated with the corresponding plasma concentrations. The Pearson correlation coefficients (R) were 0.987 (P <0.01) and 0.985 (P <0.01), respectively. Conclusion For the first time, HPLC method was developed for the simultaneous detection of trace amount of loratadine in saliva and plasma. The concentration of loratadine in saliva and plasma was correlated well. During the pharmacokinetics study and clinical drug concentration monitoring Saliva can be considered instead of plasma samples for analysis.