两种诺氟沙星盐及其注射剂的高效液相色谱分析及其稳定性探讨

Determination and Preliminary Stability Study of Norfloxacin in Bulk and Dosage Forms by HPLC

诺氟沙星为新一代的喹诺酮类抗菌药,是治疗尿路感染、淋病及其他内源性感染的首选药物。由于其水溶性较差,影响其生物利用度,为此研制了诺氟沙星的两种水溶性盐(S_1,S_2),并制成了相应的注射剂。为控制质量及研究其稳定性,有必要建立一个简单、快速的定量方法。有关诺氟沙星的测定。

A simple, precise and stability-indicating HPLC method was established for the analysis of nortloxacin in two newly developed norfloxacin salts both in bulk forms and in injections. The eluent for Hypersil ODS column was methanol-water-diethylamine (50 : 50 : 0. 4, V/V/V) with its apparent pH 5. 5. The method showed a good linearity in the range of 5～63 μg/ml for norfloxacin with relative coefficient 0.9999. Samples were simply dissolved in the eluent, filtered and injected to HPLC. The coefficient variations were less than 1.5% for the bulk drugs and 1.2% for injections. This method can be applied to the stability studies of norfloxacin in preparations.