High Performance Liquid Chromatographic Method Development and Its Validation for Salbutamol
Selvadurai Muralidharan *
Faculty of Pharmacy, AIMST University, Semeling, Bedong, Malaysia.
Jayaraj Kumar
Faculty of Pharmacy, AIMST University, Semeling, Bedong, Malaysia.
*Author to whom correspondence should be addressed.
Abstract
Aims: A simple and sensitive high performance liquid chromatographic (HPLC) method was developed for quantification of salbutamol in rat plasma. Terbutaline was used as an internal standard (IS).
Study Design: Validation study.
Methodology: The present method used solid phase extraction of salbutamol from rat plasma. Chromatographic separation achieved isocratically on reversed-phase c18 column (250 × 4.6 mm, 5μ) and the column effluent was monitored by uv detector at 276 nm. The mobile phase used was acetonitrile: 50mm ammonium acetate (ph 7.0), (80: 20 % v/v) at a flow rate of 1.0 ml/min.
Results and Discussion: This method was linear over the range of 50.0 – 1000.0 ng/ml with regression coefficient greater than 0.99.
Conclusion: The method was found to be precise, accurate and specific during the study. The simplicity of the method allows for application in laboratories that lack sophisticated analytical instruments such as LC–MS/MS or GC–MS/MS that are complicated, costly and time consuming rather than a simple HPLC–UV method. The method was successfully applied for pharmacokinetic study of salbutamol in rats.
Keywords: Simple Method, high performance liquid chromatography, validation, salbutamol, rat plasma, pharmacokinetic study.