固体脂质纳米颗粒中氟哌啶醇体外研究的高效液相色谱新方法的建立与验证

M. Yasir, U. Sara, I. Som, Lubhan Singh
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引用次数: 2

摘要

建立了一种简便、灵敏的高效液相色谱法,用于研究氟哌啶醇固体脂质纳米颗粒(SLNs)的体外释药。该方法也可用于药物分析,以检测所研制的sln的保质期。以C18柱为固定相进行色谱分离。流动相为100 mM/L磷酸二氢钾-乙腈- tea (10:90:0.1, v/v/v), o-磷酸调节pH至3.5。流动相流速为2 ml/min,采用紫外/可见检测器在230 nm处对洗脱液进行监测。对方法进行了线性度、精密度、准确度、重现性、检出限和定量限的验证。氟哌啶醇在1 ~ 60 μg/mL范围内呈线性关系。定量限和定量限分别为0.045和0.135 μg/ml。载药SLNs在24 h内的缓释最大值为95.52±5.21%,4℃下的保质期为2.31年。
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Development and Validation of a New HPLC Method for In-vitro Studies of Haloperidol in Solid Lipid Nanoparticles
A simple and sensitive HPLC method was developed and validated for the study of in-vitro drug release from haloperidol loaded solid lipid nanoparticles (SLNs). The method was also used for the analysis of drug for detection of shelf life of developed SLNs. Chromatogram separation was achieved using C18 column as stationary phase. The mobile phase consisted of 100 mM/L potassium dihydrogen phosphate–acetonitrile-TEA (10:90:0.1, v/v/v) and the pH was adjusted with o-phosphoric acid to 3.5. Flow rate of mobile phase was 2 ml/minute and eluents were monitored at 230 nm using UV/VIS detector. The method was validated for linearity, precision, accuracy, reproducibility, limit of detection (LOD) and limit of quantification (LOQ). Linearity for haloperidol was in the range of 1-60 μg/mL. The value of LOD and LOQ was found to be 0.045 and 0.135 μg/ml respectively. The drug loaded SLNs showed sustained drug release with maximum value of 95.52 ± 5.21% in 24 h. The shelf life of SLNs formulation was found to be 2.31 years at 4°C.
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