Asian Journal of Research in Chemistry

  • Year: 2009
  • Volume: 2
  • Issue: 1

Development and Validation of RP-HPLC for the Rabeprazole sodium in Pharmaceutical formulations and Human Plasma

  • Author:
  • Prasanna Reddy Battu1,, MS Reddy2
  • Total Page Count: 3
  • DOI:
  • Page Number: 49 to 51

1Dept. Quality Control and Analytical R and D, Smilax Laboratories Limited, Jeedimetla, Hyderabad-500055, A.P, India

2Department of Entomology and Plant Pathology, Auburn University, USA

Abstract

A simple, selective, accurate high Performance Liquid Chromatographic (HPLC) method was developed and validated for the analysis of Rebeprazole sodium. Chromatographic separation achieved isocratically on a C18 column [Use Inertsil C18, 5μ, 150 mm x 4.6 mm] utilizing a mobile phase of acetonitrile/phosphate buffer (70:30, v/v, pH 7.0) at a flow rate of 0.8 ml/min with UV detection at 228 nm. The retention time of Rabeprazole sodium was 2.44 min. The method is accurate (99.15–101.85%), precise (intra-day variation 0.13–1.56% and inter-day variation 0.30–1.60%) and linear within range 0.1–30μg/ml (R2=0.999) concentration and was successfully used in monitoring left over drug. The detection limit of Rabeprazole sodium at a signal-to-noise ratio of 3 was 1.80ng/ml in human plasma while quantification limit in human serum was 5.60 ng/ml. The proposed method is applicable to routine analysis of Rabeprazole sodium in pharmaceutical formulations as well as in human plasma samples.

Keywords

Rabeprazole sodium, RP-HPLC, Validation, Human blood samples, Pharmaceutical dosage forms