HIGH-PERFORMANCE LIQUID-CHROMATOGRAPHIC DETECTION OF RESIDUAL FORMALDEHYDE IN A HEPATITIS-A VACCINE BY USE OF HYDRALAZINE

被引：5

作者：

COHEN, HP

TWAY, PC

机构：

[1] Analytical Research Department (RY80M-112), Merck Research Laboratories, Rahway, New Jersey, 07065

来源：

JOURNAL OF LIQUID CHROMATOGRAPHY | 1993年 / 16卷 / 08期

关键词：

D O I：

10.1080/10826079308021680

中图分类号：

Q5 [生物化学];

学科分类号：

071010 ; 081704 ;

摘要：

An assay was developed that is capable of detecting levels of residual formaldehyde in viral vaccine dosage formulations to 0.01 mug/mL. The assay employs incubation of dosage formulation suspensions with hydralazine hydrochloride under mildly acidic conditions and elevated temperatures. Formaldehyde present is derivitized to yield s-triazolo-[3,4-a]-phthalazine. Selectivity of the assay is enhanced by performing reverse phase HPLC after the reaction, and monitoring elution of the fluorescent product. The presence of insoluble aluminum hydroxide in dosage formulations does not affect formaldehyde recovery. The assay was used to determine formaldehyde levels in dosage formulations and in in-process samples of a newly developed Hepatitis A vaccine.

引用

页码：1667 / 1684

页数：18

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