HIGH-PERFORMANCE LIQUID-CHROMATOGRAPHIC DETERMINATION OF NIFEDIPINE AND A TRACE PHOTODEGRADATION PRODUCT IN HOSPITAL PRESCRIPTIONS

HIGH-PERFORMANCE LIQUID-CHROMATOGRAPHIC DETERMINATION OF NIFEDIPINE AND A TRACE PHOTODEGRADATION PRODUCT IN HOSPITAL PRESCRIPTIONS
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DOI:
10.1016/0731-7085(92)80012-c
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发表时间:
1992-01-01
影响因子:
3.4
通讯作者:
SUGAWARA, K
SUGAWARA, K
中科院分区:
医学3区
文献类型:
--
作者:
OHKUBO, T;NORO, H;SUGAWARA, K

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建立了一种高效液相色谱法测定医院处方制剂中硝苯地平和微量光降解产物的方法。经液液萃取后,硝苯地平及其光降解产物采用反相系统进行色谱分析,该系统采用254 nm紫外检测和两种内标。用相同的方法与硝苯地平一起测定粉碎片中的微量光降解产物。该方法以对硝基苯地平为内标可测定0.5 ~ 5.0 μ g硝基苯地平,以5-羟基硝基苯地平为内标可测定0.01 ~ 0.5 μ g光降解产物。标准误差不超过8.4%。该方法可用于硝苯地平片剂和粉剂的光稳定性研究。
A HPLC method is developed for the assay of nifedipine and trace amounts of a photodegradation product in pulverized tablets used in the preparation of hospital prescriptions. After liquid-liquid extraction, nifedipine and its photodegradation product are chromatographed using a reversed-phase system which involves UV detection at 254 nm and the use of two internal standards. The trace photodegradation product in pulverized tablets is determined along with nifedipine by the same procedure. The method is capable of determining 0.5-5.0-mu-g of nifedipine using p-nitronifedipine as the internal standard and 0.01-0.5-mu-g of the photodegradation product using 5-hydroxynifedipine as the internal standard. The standard error is found to not exceed 8.4%. The methods are useful for the study of the disposition or photostability of nifedipine in tablets and pulverized tablets.