title: Comparison of UV spectrophotometry and high performance liquid chromatography methods for the determination of repaglinide in tablets.
abstract: BACKGROUND
  Repaglinide is a miglitinide class of antidiabetic drug used for the treatment of type 2 diabetes mellitus. A fast and reliable method for the determination of repaglinide was highly desirable to support formulation screening and quality control.
  
  
  OBJECTIVE
  UV spectrophotometric and reversed-phase high performance liquid chromatography (RP-HPLC) methods were developed for determination of repaglinide in the tablet dosage form.
  
  
  METHODS
  The UV spectrum recorded between 200 400 nm using methanol as solvent and the wavelength 241 nm was selected for the determination of repaglinide. RP-HPLC analysis was carried out using Agilent TC-C18 (2) column and mobile phase composed of methanol and water (80:20 v/v, pH adjusted to 3.5 with orthophosphoric acid) at a flow rate of 1.0 ml/min. Parameters such as linearity, precision, accuracy, recovery, specificity and ruggedness are studied as reported in the International Conference on Harmonization (ICH) guidelines.
  
  
  RESULTS
  The developed methods illustrated excellent linearity (r(2) > 0.999) in the concentration range of 5-30 μg/ml and 5-50 μg/ml for UV spectrophotometric and HPLC methods, respectively. Precision (%R.S.D < 1.50) and mean recoveries were found in the range of 99.63-100.45% for UV spectrophotometric method and 99.71-100.25% for HPLC method which shows accuracy of the methods.
  
  
  CONCLUSIONS
  The developed methods were found to be reliable, simple, fast, accurate and successfully used for the quality control of repaglinide as a bulk drug and in pharmaceutical formulations.
authors.affiliation: Department of Pharmaceutical Chemistry, Sharad Pawar College of Pharmacy, Nagpur, Maharashtra, India.
authors.forename: Seema M
authors.initials: SM
authors.lastname: Dhole
authors.forename: Pramod B
authors.initials: PB
authors.lastname: Khedekar
authors.forename: Nikhil D
authors.initials: ND
authors.lastname: Amnerkar
keywords: Method validation; RP-HPLC; quantitative analysis; repaglinide