Quantitative
Determination of Metformin Hydrochloride in Tablet
Formulation Containing Croscarmellose Sodium as
Disintegrant by HPLC and UV Spectrophotometry
P Umapathi 1*,
J.Ayyappan2 and S Darlin Quine3
1Department
of Analytical Research and Development, Micro Labs Ltd,
67/68-A, Third Phase, Peenya Industrial Area, Bangalore
560 058, 2SASTRA University, Thanjavur,
Tamil
Nadu, 3PG
and Research Department of Chemistry, Government Arts
College,
Chidambaram, India.
*For correspondence:
Email:
varasubio@rediffmail.com
Received: 18 May
2011 Revised
accepted: 2 December 2011
Tropical Journal of
Pharmaceutical Research, February 2012; 11(1):
99-106
http://dx.doi.org/10.4314/tjpr.v11i1.14
Abstract
Purpose: To develop and validate a suitable
method for the assay of metformin hydrochloride (HCl) in
tablets containing croscarmellose sodium as an additive.
Methods: Methanol and ethanol (99%) were assessed
as solvents for sample preparation for the assay of
metformin HCl in tablets containing croscarmellose
sodium by high performance liquid chromatography (HPLC)
and ultra violet spectrophotometric (UV) methods. The
proposed method was subjected to validation tests.
Results: Recovery of metformin HCl from the
placebo-spiked sample was 95.1 to 96.9 % as per BP and
USP methods compared with 99.3 to 100.8 % when analyzed
by the proposed method. The use of methanol and ethanol
as solvents resolved the problem of retention of
metformin HCl by croscarmellose sodium in solution
during the preparation of sample solution.
Conclusion: The modified UV and HPLC methods are
suitable for the determination of metformin HCl in
tablets both in the presence and absence of
croscarmellose sodium. The method is specific, precise,
accurate, robust, rugged and gives a linear response for
the quantitative estimation of metformin HCl in tablet
formulation.
Keywords: Tablets; Metformin HCl assay;
Croscarmellose sodium; Ethanol; Methanol; HPLC, UV.
