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Volume 20, Issue 9
  • ISSN: 1573-4129
  • E-ISSN: 1875-676X

Abstract

Aims

The aim of this study is to develop a sensitive, specific, rapid, and precise reverse-phase high-performance liquid chromatography (RP-HPLC) method and validate it to determine the Roflumilast in rat plasma.

Background

This study was aimed at developing a simple HPLC method for the detection of Roflumilast in rat plasma after ingestion of nanoparticles into the rat. A bioanalytical method was developed and validated.

Methodology

The drug sample (Roflumilast) was eluted isocratically using a mobile phase of Ammonium acetate buffer (pH = 7.0), acetonitrile, and methanol (20:40:40, v/v/v) made up the mobile phase on a Phenomenex C-18 (150mm x 4.68mm) pore size 5-micron analytical column. The drug was quantitatively determined at a UV wavelength of 254 nm using a standard calibration curve spanning the range of 1.5, 3.0, 4.5, 6.0, 7.5 μg/mL-1.

Results

The results showed that the limits of quantitation (LOQ) and detection (LOD) were 0.18 μg/ml and 0.54μg/ml, respectively. For both the intra-day and inter-day analysis, relative standard deviation (% RSD) was less than 2%, and the drug’s percentage accuracy was between 96% and 98%.

Conclusion

As per the established protocols, the developed method was quantitatively assessed for its intended use in terms of specificity, linearity, accuracy, precision, robustness, and sensitivity analysis. Roflumilast-loaded nanoparticles were effectively used to determine the drug entrapment efficiency using the currently validated RP-HPLC method. Besides, highly efficient drug extraction from plasma was attained, and mobile phase composition was suitable to the pharmacokinetic study of Roflumilast-loaded nanoparticles in rats.

© 2024 Bentham Science Publishers
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2024-12-13
2025-04-24

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/content/journals/cpa/10.2174/0115734129348436241209110149
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Development and Validation of RP-HPLC Method for Roflumilast Nano Particles in Rat Plasma for Pharmacokinetic Study Analysis
Current Pharmaceutical Analysis 20, 1083 (2024); https://doi.org/10.2174/0115734129348436241209110149
/content/journals/cpa/10.2174/0115734129348436241209110149
/content/journals/cpa/10.2174/0115734129348436241209110149
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  • Article Type:     Research Article
Keyword(s): determination; ICH guidelines; plasma; quantification; roflumilast; RP-HPLC

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