罗通定在唾液和皿浆中浓度的测定及相关性分析

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）C18柱（250mm×4．6mm，5μm）；流动相为甲醇：水（70：30，V/V）；流速1．0mL·min^-1；柱温30℃；检测波长281nm。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Pemarson相关分析。结果罗通定的唾液和血浆浓度在0．1-20．0mg·L^-1和0．5．40．0mg·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0．1mR·L^-1、100．97％-107．50％和0．5mg·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0．9,37（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，

Correlation analysis between levels of rotundine in rats saliva and plasma measured by HPLC

AIM To develop a HPLC method for the detennination of mtundine in rats saliva and plasma anu investigate the correlation between saliva and plasma concentrations of rotu, ndine after a single dose of intravenous injection in rats. METHODS The separation was performed on a Diamonsil（R）C18 column （250 mm × 4.6 mm, 5 μm） with methanol-water （70：30, V/V） as mobile phase at the flow rate of 1.0 mL·min^-1 The UV detector was set at 281 nm. Pearson correlation analysis was used to assess the correlation between ρs（ concentrations in parotid gland or submaxillary gland） and ρp（plasma concenuution）. RESULTS Calibration curves were linear within the range of 0.1 - 20.0mg·L^-1 in saliva and 0.5 - 40.0 mg·L^-1 in plasma. The LOQ was 0.1mg·L^-1 in saliva and 0.5 mg·L^-1 in plasma and the average recovery for saliva and plasma samples ranged from 100.97% - 107.5% and 98.30% - 111.20% ,respectively. The RSD for intra-day and inter-day precision of quality control （QC） samples, evaluated both in saliva and plasma, were all within 10%. A statistically significant correlation was found between ρs and ρp （R = 0. 987 for parotid gland, P 〈 0.01 ; R = 0. 985 for submaxillary gland, P 〈 0.01）. CONCLUSION The results suggest that saliva might be served as an alternative for plasma in pharmacokinetic studies and clinical drug monitoring for rotundine.