Development and validation of a sensitive liquid chromatographic-tandem mass spectrometric method for the determination of cromolyn sodium in human plasma.
Cromolyn sodium is a safe compound with potent anti-allergic properties when used locally or topically. Clinical data from systemic exposure is not available because of the poor GI absorption when given orally. In order to evaluate a new approach to enhance the absorption and bioavailability of cromolyn sodium, a sensitive assay was needed to support an oral-dose study in humans. This paper describes a liquid chromatographic-tandem mass spectrometric (LC-MS-MS) method for the analysis of cromolyn sodium in human plasma. The method consists of a two-step extraction with subsequent analysis using a high-performance liquid chromatography electrospray tandem mass spectrometer system. The compounds were eluted isocratically on a C(18) column followed by a backflush. The total run time is 6 min. The standard curve of cromolyn sodium was over the range of 0.313 to 750 ng/mL with a lower limit of quantitation (LLOQ) of 0.313 ng/mL when 0.5 mL of plasma was used for analysis. The percent coefficient of variation (C.V.) for accuracy and precision (inter-assay and intra-assay) was less than 15% over the validated concentration range and the coefficients of determination, r(2), were >0.991577. The method is simple, sensitive, and selective, and has been successfully utilized for oral cromolyn sodium clinical studies.
Lin
Zhongping John
ZJ
Avantix Laboratories, Inc., 57 Read's Way, New Castle, DE 19720, USA. linj@avantixlabs.com
Abbas
Richat
R
Rusch
Lorraine M
LM
Shum
Linyee
L
D002851:Chromatography, High Pressure Liquid / Q000379:methods*; D004205:Cromolyn Sodium / Q000097:blood*; D006801:Humans; D013058:Mass Spectrometry / Q000379:methods*; D012680:Sensitivity and Specificity
D004205:Cromolyn Sodium