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World Journal of Pharmaceutical
and Medical Research

An International Peer Reviewed Journal for Pharmaceutical and Medical Research and Technology
An Official Publication of Society for Advance Healthcare Research (Reg. No. : 01/01/01/31674/16)
ISSN 2455-3301
IMPACT FACTOR: 4.639

ICV : 78.6

Abstract

BIOANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF BUDESONIDE IN HUMAN PLASMA BY LIQUID CHROMATOGRAPHY AND ITS APPLICATION TO A PHARMACOKINETIC STUDY

Seelam Sharath Chandra*, Venugopal Miyyapuram, K. Soujanya, Rakesh Kumar Jat and
Nageswara Rao Pilli

ABSTRACT

Budesonide is a nonhalogenated corticosteroid exhibits potent glucocorticoid and weak mineralocorticoid activity. In the present research work, a novel and rapid LC-MS/MS method was developed and validated for the determination of budesonide in human plasma. Levonorgestrel was used as an internal standard (IS) to quantify budesonide in plasma. Sample preparation was performed by simple liquid-liquid extraction method and chromatographed on a C8 column with isocratic mobile phase of acetonitrile and 5mM ammonium formate in 0.1% formic acid in the ratio of 60:40, v/v used for the separation of extracted analyte. The budesonide linearity was established in the range of 0.10 – 3.00 ng/mL. Variety of validation parameters namely precision and accuracy, linearity, dilution integrity, recovery and matrix effect were well within the acceptable limits. Also, the stability of analyte was extensively evaluated in plasma as well in extracted samples and results met the acceptance criteria as per the regulatory guidelines.

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