Human Journals
Research Article
October 2017 Vol.:10, Issue:3
© All rights are reserved by Shraddha S. Ghodke
Simultaneous Spectroscopic Estimation by Ratio Derivative Method of
Metformin Hydrochloride and Gliclazide in Uncoated Bilayered Extended
Release Combined Solid Dosage Form and its Application to Dissolution Studies
www.ijppr.humanjournals.com
Keywords: Metformin hydrochloride, Gliclazide, Bilayered
Extended-release solid dosage form, Dissolution studies.
ABSTRACT
A simple, rapid, precise & efficient UV Spectroscopic method
for simultaneous analysis of metformin hydrochloride and
gliclazide in extended release combined tablet solid dosage
form has been developed and validated. Practically no
interference from tablet excipients was observed in these
developed methods. As their λmax does not differ more than 20
nm, (232 nm for Metformin Hydrochloride and 229.5 nm for
Gliclazide); hence, absorption corrected method was tried for
their simultaneous estimation in extended-release tablet
formulation. Quantitative estimation of GLZ was carried out by
subtracting interference of MTF using experimentally
calculated absorption factor. Both the methods are accurate,
simple, rapid, precise, reliable, sensitive, reproducible and
economical as per ICH guidelines. The values of % RSD and
correlation of coefficient were satisfactory and results of the
formulation analysis and result of the recovery study indicate
that there is no interference due to excipients present in the
formulation. It can be easily and conveniently adopted for
routine quality control analysis. The absorption corrected
method was successfully applied for the dissolution study.
Validation revealed the dissolution method is specific, rapid,
accurate, precise, reliable and reproducible.
Shraddha S. Ghodke
Department of Pharmaceutical Chemistry, Maharashtra
Institute of Pharmacy, Faculty of Pharmacy, University
of Pune, Maharashtra, India
Submission: 22 September 2017
Accepted: 3 October 2017
Published: 30 October 2017