title: Development and validation of RP-HPLC method with ultraviolet detection for estimation of montelukast in rabbit plasma: Application to preclinical pharmacokinetics.
abstract: OBJECTIVE
  To develop a liquid-liquid extraction based reverse phase liquid chromatography method for estimation of montelukast in rabbit plasma.
  
  
  METHODS
  Chromatographic separation was carried out using Phenomenex Luna C18 column (250 mm × 4.6 mm × 5 μm) with mobile phase composed of ammonium acetate buffer (20 Mm), pH 5.5 and acetonitrile in 20:80, v/v ratio. The analyte was monitored with UV detector at 345 nm. The developed method was validated with respect to linearity, accuracy, precision, specificity and stability.
  
  
  RESULTS
  The peak area ratio of montelukast (MKS) to that of internal standard was used for the quantification of samples. Calibration curves were linear in the concentration range of 20-2000 ng mL(-1). The LOD and LLOQ of present method were found out to be 10 ng mL(-1) and 20 ng mL(-1) respectively. The intra-day and inter-day %CV values for MKS were below 6.06% and 8.43%. Intra-day and inter-day accuracies were within 95.81% and 110.90%, respectively. Extraction recoveries of drug from rabbit plasma were >66.47%.
  
  
  CONCLUSIONS
  A simple, alternative, reproducible and sensitive HPLC-UV method was developed for MKS that can be used in preclinical pharmacokinetics.
authors.affiliation: Department of Pharmaceutics, Manipal College of Pharmaceutical Sciences, Manipal University, Manipal 576104, Karnataka, India.
authors.forename: Om Prakash
authors.initials: OP
authors.lastname: Ranjan
authors.affiliation: Department of Pharmaceutics, Manipal College of Pharmaceutical Sciences, Manipal University, Manipal 576104, Karnataka, India.
authors.forename: Usha Y
authors.initials: UY
authors.lastname: Nayak
authors.affiliation: Department of Pharmaceutics, Manipal College of Pharmaceutical Sciences, Manipal University, Manipal 576104, Karnataka, India.
authors.forename: Meka Sreenivasa
authors.initials: MS
authors.lastname: Reddy
authors.affiliation: Department of Pharmaceutical Quality Assurance, Manipal College of Pharmaceutical Sciences, Manipal University, Manipal 576104, Karnataka, India.
authors.forename: Swapnil J
authors.initials: SJ
authors.lastname: Dengale
authors.affiliation: Department of Pharmaceutical Quality Assurance, Manipal College of Pharmaceutical Sciences, Manipal University, Manipal 576104, Karnataka, India.
authors.forename: Prashant B
authors.initials: PB
authors.lastname: Musmade
authors.affiliation: Department of Pharmaceutical Management, Manipal College of Pharmaceutical Sciences, Manipal University, Manipal 576104, Karnataka, India.
authors.forename: Nayanabhirama
authors.initials: N
authors.lastname: Udupa
keywords: HPLC; Montelukast; Pharmacokinetics; Rabbit plasma; UV detection