Simultaneous Spectrophotometric Determination of
Valsartan and Ezetimibe in Pharmaceuticals
Sridevi
Ramachandran1,2*,
Badal Kumar Mandal1 and
Sameer G Navalgund2
1School
of Advance Sciences, Vellore Institute of Technology
University, Vellore Tamil Nadu-632041,
2Analytical
Research Department,
International Specialty Products (India) Private
Limited, 2nd and 3rd Floor Bhupal
Towers Somajiguda, Hyderabad Andhra Pradesh - 500082,
India.
For correspondence:
E-mail:
sri_devir@yahoo.com
Tel: +91-040-44747000
Received: 9 March
2011 Revised
accepted: 23 October, 2011
Tropical
Journal of Pharmaceutical Research, December 2011;
10(6): 809-815
http://dx.doi.org/10.4314/tjpr.v10i6.15
Abstract
Purpose:
To develop a
direct, simple and extraction-free spectrophotometric
method for the simultaneous estimation of valsartan and
ezetimibe in pharmaceuticals.
Methods:
A
spectrophotometric method for the determination of
valsartan and ezetimibe was developed using acidic dyes,
namely,
bromophenol
blue (BPB) and bromocresol green (BCG). The method was
based on selective ion-pair formation between valsartan
and the acidic dye. The yellow coloured ion-pair induces
a bathochromic shift in the spectrum with maximum
absorbance at 425 and 428 nm for BPB and BCG,
respectively. The developed method was validated as per
ICH guidelines.
Results:
With BPB, the
ion-pair formed obeyed Beer`s law in the ranges 5 - 40
and 1 - 50 µg/mL for valsartan and ezetimibe,
respectively. The assay data for valsartan and ezetimibe
were, 99.39 ± 0.53
and 98.17 ± 0.91 %,
respectively,
for the commercial formulation, and 99.41 ± 0.48 and
98.16± 0.89 %,
respectively,
for the developed formulation.
The method was validated and the correlation coefficient
for valsartan and ezetimibe were 0.995 and 0.999,
respectively. Recovery was in the range 99.3 - 100.3 %.
Conclusion:
The proposed
method is reproducible, accurate, robust and suitable
for the simultaneous quantitative analysis of the
studied drugs in bulk and dosage formulation.
Keywords:
Valsartan, Ezetimibe, Bromophenol blue, Bromocresol
green,
Spectrophotometric method.
