验证的反相高效液相色谱法测定兔血浆中 felodipine 的含量：在生物等效性研究中的应用。

Validated RP-HPLC method for quantification of felodipine in rabbit plasma: Application in a bioequivalence study.

作者信息

Salunkhe N H, Jadhav N R, Bhinge S D

机构信息

Department of Pharmaceutics, Bharati Vidyapeeth College of Pharmacy, Kolhapur 416013, Maharashtra state, India.

出版信息

Ann Pharm Fr. 2019 Jan;77(1):15-27. doi: 10.1016/j.pharma.2018.08.002. Epub 2018 Sep 19.

DOI:10.1016/j.pharma.2018.08.002

PMID:30243471

Abstract

OBJECTIVE

The aim of present study was to develop a simple, rapid, selective, sensitive and robust reverse phase high performance liquid chromatographic method for quantification of felodipine in rabbit plasma at the wavelength of 360nm.

METHOD

Protein was precipitated from rabbit plasma sample by addition of acetonitrile as a vehicle. An isocratic elution of samples was performed on capcell pak C DD S5 column (4.6mm×250mm particle size 5μm) column with mobile phase consisting 5mM Phosphate Buffer (pH 4.8 adjusted with dilute ortho-phosphoric acid solution): acetonitrile (25:75:v/v) delivered at flow rate 1.0mLmin.

RESULT

A good linear response was achieved over the range of 0.25-20.00μgmL. LODs and LOQs for felodipine were found to be 0.055 and 0.201μgmL, respectively. The method was quantitatively evaluated in terms of linearity, precision, accuracy (recovery), selectivity robustness and stability study as per standard guidelines. The validated RP-HPLC method was successfully applied for the bioavailability studies of felodipine. The pharmacokinetic parameters were calculated for all the investigated drugs in rabbit after single-dose administrations of pure drug and formulation of felodipine. Finally, the obtained results for the application of the proposed RP-HPLC method proved its efficiency to be applied to the therapeutic drug monitoring (TDM) and bioequivalence (BE) studies.

CONCLUSION

Thus, developed method is simple, convenient and suitable for the analysis of felodipine in bulk and pharmaceutical formulations.

摘要

目的

本研究的目的是开发一种简单、快速、选择性好、灵敏且稳健的反相高效液相色谱法，用于在360nm波长下定量测定兔血浆中的非洛地平。

方法

通过加入乙腈作为媒介从兔血浆样品中沉淀蛋白质。在资生堂C18 S5柱（4.6mm×250mm，粒径5μm）上对样品进行等度洗脱，流动相由5mM磷酸盐缓冲液（用稀正磷酸溶液调节pH至4.8）：乙腈（25:75，v/v）组成，流速为1.0mL/min。

结果

在0.25 - 20.00μg/mL范围内获得了良好的线性响应。非洛地平的检测限和定量限分别为0.055和0.201μg/mL。按照标准指南，从线性、精密度、准确度（回收率）、选择性、稳健性和稳定性研究等方面对该方法进行了定量评估。经过验证的反相高效液相色谱法成功应用于非洛地平的生物利用度研究。在单次给予非洛地平纯药物和制剂后，计算了兔体内所有研究药物的药代动力学参数。最后，所提出的反相高效液相色谱法的应用结果证明了其在治疗药物监测（TDM）和生物等效性（BE）研究中的应用效率。