Development and Validation of a Novel Method for the Quantification of Cetirizine and Levocetirizine in Dried Breast Milk Spots
Year: 2016
Type: article
Abstract: We developed a method for the analysis of anti-allergic drugs cetirizine/levocetirizine in dried breast milk spot (DMS) samples to facilitate sample transport for lactating mothers. DMS were prepared by spotting 25 - 35 µL of human breast milk on each circle of Whatman® indicating FTA® DMPK cards. The 8 mm disks from the central part of the DMS samples were punched out and extracted using acetonitrile/water. Chromatographic separation was achieved on a reverse-phase C18 column with 10 mM ammonium formate / 0.1% formic acid buffer in water/acetonitrile. Detection was by a triple quadrupole mass spectrometer equipped with a heated electrospray ionization source. The method was validated with the range 0.5 - 100 ng/mL for cetirizine and levocetirizine. Observed cetirizine and levocetirizine concentration of DMS using spiked breast milk was strongly correlated with the sample extracted from spiked breast milk. DMS using breast milk donated from cetirizine administrated patients were also correlated with the sample extracted from whole breast milk. The assay was validated over the concentration range 0.5 - 100 ng/mL. Accuracy ranged within 15% and precision did not exceed 15％. The average recovery of cetirizine and levocetirizine from DMS was 86.1% and 84.9%, respectively. Stability in DMS at room temperature, 4℃ and -20℃ for 14 days was demonstrated. The validated method, proved stability in DMS and the correlation study showed the capability of the DMS method to be used as a mode of transport for breast milk in a clinical study about drug transfer to breast milk.
Institution: National Center For Child Health and Development
Language: English
Subfield: Analytical Chemistry
Field: Chemistry
Domain: Physical Sciences
Open Access status: bronze
OpenAlex ID: W2763885166