Ankara University, Institute of Forensic Sciences, Department of Forensic Toxicology, Ankara, Turkey.
Ankara University, Institute of Forensic Sciences, Department of Forensic Toxicology, Ankara, Turkey.
J Pharm Biomed Anal. 2022 Sep 20;219:114966. doi: 10.1016/j.jpba.2022.114966. Epub 2022 Jul 26.
The aim of the present study is to develop the polymeric nanoparticulate drug delivery systems of piroxicam and to evaluate the in-vitro characteristics such as entrapment efficiency, surface morphology, in-vitro drug release performance, etc. For this reason, a novel HPLC methodology was developed for the determination of piroxicam from its bulk form, pharmaceutical preparation, and nanoparticulate delivery systems. Furthermore, the developed formulation was applied to the rats and the biological samples (plasma, liver, heart, spleen, kidney, and lung homogenates) were analyzed by the developed HPLC method following a salting-out assisted liquid-liquid extraction strategy for the first time in the literature. A Kinetex C18 analytical column (150 mm × 4.6 mm i.d., 5 µm) was used as a stationary phase with a 0.8 mL/min flow rate of acetonitrile: phosphate buffer (40:60, v/v), the column oven was adjusted to 40 °C and detection wavelength is set to 360 nm. Developed method were validated as per selectivity, linearity, LOD, LOQ, precision, and accuracy specified in the International Council for Harmonisation guidelines. As a result of the present study, it has been shown that the analysis of piroxicam from the bulk form, pharmaceutical preparation, developed polymeric-based drug delivery system, and biological samples can be successfully performed and no interferences were observed in any matrix. The developed method was also successfully utilized to study the tissue distribution of piroxicam in rats.
本研究旨在开发吡罗昔康的聚合物纳米药物传递系统，并评估其体外特性，如包封效率、表面形态、体外药物释放性能等。为此，开发了一种新的 HPLC 方法，用于从吡罗昔康的原料药、制剂和纳米递药系统中测定吡罗昔康。此外，首次应用所开发的制剂，通过盐析辅助液-液萃取策略，在文献中首次对大鼠生物样品（血浆、肝、心、脾、肾和肺匀浆）进行分析。采用 Kinetex C18 分析柱（150mm×4.6mm i.d.，5μm）作为固定相，以 0.8mL/min 的流速洗脱乙腈：磷酸盐缓冲液（40:60，v/v），柱温箱设定为 40°C，检测波长设定为 360nm。所开发的方法按照国际协调委员会（ICH）指南规定的选择性、线性、LOD、LOQ、精密度和准确度进行了验证。本研究表明，从原料药、制剂、开发的聚合物基药物传递系统和生物样品中分析吡罗昔康，可以成功进行，任何基质中均未观察到干扰。所开发的方法还成功用于研究吡罗昔康在大鼠体内的组织分布。
