Development and validation of a reversed-phase ion-pair high-performance liquid chromatographic method for the determination of risedronate in pharmaceutical preparations

Anal Chim Acta. 2007 Feb 12;584(1):153-9. doi: 10.1016/j.aca.2006.11.012. Epub 2006 Nov 11.

Abstract

A stability indicating, reversed-phase ion-pair high-performance liquid chromatographic method was developed and validated for the determination of risedronate in pharmaceutical dosage forms. The determination was performed on a BDS C(18) analytical column (250 mm x 4.6 mm i.d., 5 microm particle size); the mobile phase consisted of 0.005 M tetrabutylammonium hydroxide and 0.005 M pyrophosphate sodium (pH 7.0) mixed with acetonitrile in a ratio (78:22, v/v) and pumped at a flow rate 1.00 mL min(-1). The ultraviolet (UV) detector was operated at 262 nm. The retention times of magnesium ascorbyl phosphate, which was used as internal standard and risedronate were 4.94 and 5.95 min, respectively. The calibration graph was ranged from 2.50 to 20.00 microg mL(-1), while detection and quantitation limits were found to be 0.48 and 1.61 microg mL(-1), respectively. The intra- and inter-day percentage relative standard deviations, %R.S.D., were less than 5.9%, while the relative percentage error, %E(r), was less than 0.4%. The method was applied to the quality control of commercial tablets and content uniformity test and proved to be suitable for rapid and reliable quality control.

MeSH terms

  • Calcium Channel Blockers / analysis*
  • Chromatography, High Pressure Liquid / methods
  • Etidronic Acid / analogs & derivatives*
  • Etidronic Acid / analysis
  • Hydrogen-Ion Concentration
  • Pharmaceutical Preparations / chemistry*
  • Reproducibility of Results
  • Risedronic Acid
  • Spectrophotometry, Ultraviolet
  • Tablets

Substances

  • Calcium Channel Blockers
  • Pharmaceutical Preparations
  • Tablets
  • Risedronic Acid
  • Etidronic Acid