Development of a New
RP-UPLC Method for the Determination of Rabeprazole
Sodium in Pharmaceutical Formulation and Application in
Dissolution Studies
K Karunakaran1*, G Navaneethan1
and KP Elango2
1Department
of Chemistry, Sona College of Technology, Anna
University, Salem 636 005, 2Department of
Chemistry, Gandhigram Rural Institute, Deemed
University, Gandhigram 624302, India
For
correspondence:
E-mail:
drkk@sonatech.ac.in
Tel: +91 427 4099998; Fax: +91 427 4099989
Received: 1 March
2011 Revised
accepted: 20 August 2011
Tropical
Journal of Pharmaceutical Research, Oct 2011;
10(5): 655-661
http://dx.doi.org/10.4314/tjpr.v10i5.15
Abstract
Purpose: To
develop a reverse phase ultra-performance liquid
chromatographic (RP-UPLC) method for the estimation of
rabeprazole sodium in tablet formulations.
Methods:
Chromatographic separation was achieved on a
Waters Acquity BEH C18
(50 x 2.1 mm, particle size 1.7 µm) column using an
isocratic method with mobile phase composed of
acetonitrile and phosphate buffer (pH 7.4) in the ratio
of 35:65 (v/v). The flow rate was 0.4 ml/min,
temperature of the column was maintained at ambient,
injection volume was 5 µL and detection was made at 280
nm. The run time was as short as 2 min. Comparison of
system performance with conventional HPLC was made with
respect to analysis time, efficiency and sensitivity.
Results: The
developed method was linear for rabeprazole sodium from
0.03 - 30 µg/ml and the linear regression obtained was >
0.999. Precision, evaluated by intra- and inter-day
assay,s had relative standard deviation (R.S.D) values
within 1.5 %. Recovery data were in the range 98.0 -
101.5 % with R.S.D. values < 1.5 %.
Conclusion: The
method is precise, accurate, linear, robust and fast.
The short retention time of 1.49 min allows the analysis
of a large number of samples in a short period of time
and, therefore, should be cost-effective for routine
analysis in the pharmaceutical industry.
Keywords: Ultra
performance liquid chromatography, Assay, Rabeprazole
sodium, Validation
