Development of salting-out extraction methodology for the determination of piroxicam from polymeric based nanocarriers and biological samples

Abstract

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.