[HPLC-MS/MS method for determination of sodium cromoglycate concentration in human plasma and its pharmacokinetics].
The study established an HPLC-MS/MS method for determining the concentrations of sodium cromoglycate in human plasma and evaluated the pharmacokinetics of nasal drops and nasal spray. A C18 column was used to separate sodium cromoglycate in plasma with a mobile phase of a mixture of ammonium-methanol (involves 50% acetonitrile) (15:85) at a flow rate of 0.4 mL x min(-1). Electronic spray ionization (ESI) and multiple-reaction monitoring (MRM) were used for the determination of sodium cromoglycate in human plasma. The linear range of the standard curve of sodium cromoglycate was from 0.3 to 20 ng x mL(-1), and the minimum concentration of detection was 0.3 ng x mL(-1). The extraction recovery was more than 94.1%, intra-day and inter-day RSD were less than 14.3%. After a single dose of sodium cromoglycate, the main pharmacokinetic parameters of nasal spray and nasal drops were as follows, T(1/2)(1.82 +/- 0.54) h, (1.59 +/- 0.52) h; Tmax (0.47 +/- 0.12) h, (0.44 +/- 0.15) h; Cmax, (9.79 +/- 4.66) ng x mL(-1), (10.88 +/- 4.05) ng x mL(-1); AUC(0-5 h)(11.52 +/- 3.46) ng x mL(-1) x h x h, (12.63 +/- 4.23) ng x mL(-1) x h, Fr(93.6 +/- 13.8)%. The method is sensitive, rapid and accurate. It is suitable for therapeutic drug monitoring and human pharmacokinetic study of sodium cromoglycate.
Xu
Xiao-yan
XY
Institute of Clinical Pharmacology, Qilu Hospital of Shandong University, Jinan 250012, China.
Zhang
Rui
R
Yuan
Gui-yan
GY
Wang
Ben-jie
BJ
Liu
Xiao-yan
XY
Guo
Rui-chen
RC
D000281:Administration, Intranasal; D018926:Anti-Allergic Agents / Q000008:administration & dosage / Q000097:blood* / Q000493:pharmacokinetics*; D019540:Area Under Curve; D002851:Chromatography, High Pressure Liquid; D004205:Cromolyn Sodium / Q000008:administration & dosage / Q000097:blood* / Q000493:pharmacokinetics*; D016903:Drug Monitoring / Q000379:methods; D006801:Humans; D008297:Male; D009330:Nebulizers and Vaporizers; D011786:Quality Control; D021241:Spectrometry, Mass, Electrospray Ionization
D018926:Anti-Allergic Agents; D004205:Cromolyn Sodium