1.
Validation with using 0.5 M Metformin Hydrochloride Hydrotropic
Solubilization Phenomenon in Pharmaceutical Combined tablet dosage
forms Esomeprazole and Itopride
Mukesh
Chandra Sharma* a, Smita Sharma b, S.C.Chaturvedi
c
a* School of Pharmacy, Devi Ahilya Vishwavidyalaya, Indore (M.P)
452001, India
b Department of Chemistry Yadhunath Mahavidyalya Bhind (M.P)
477001 India
c Shri Arvindo Institute of Pharmacy Ujjain Road Indore (M.P)
453111 India
* Corresponding Author: Mukesh Chandra Sharma, School of
Pharmacy, Devi Ahilya Vishwavidyalaya, Takshshila Campus, Khandwa
Road, Indore- 452 001, Madhya Pradesh, India, Fax: +91 731 2467888,
Tel. : +91 731 2100605
E-mail:
mukeshcsharma@yahoo.com
Abstract:
Attempting to minimize these drawbacks, three new, simple,
accurate, environmental friendly, cost effective, safe,
sensitive spectrophotometric methods have been developed for
simultaneous estimation of Esomeprazole and Itopride in
tablet dosage form using 0.5 Metformin hydrochloride aqueous
solutions, as a hydrotropic agent. Various organic solvents
like methanol, chloroform, alcohol, dimethyl formamide;
acetonitrile, hexane, acetone and carbon tetrachloride have
been employed for solubilization of poorly water-soluble
drugs for spectrophotometric estimations. Aqueous solubility
of these model drugs were enhanced to a great extent 102 and
141 fold for Esomeprazole and Itopride in 0.5 Metformin
hydrochloride solutions respectively. 0.5 Metformin
hydrochloride solution and additives of tablet did not
interfere in analysis, as 0.5 Metformin hydrochloride did
not show any absorbance above 316 nm. In 0.5 Metformin
hydrochloride solution, Esomeprazole and Itopride shows
maximum absorbance at wavelength 327 nm and 315 nm
respectively and isobestic point was observed at 286 nm.
Beer’s law was obeyed in the concentration range 5-35 µg/ml
for Esomeprazole and 5-40µg/ml for Itopride. Method-I is
based on simultaneous equation method and method II is based
on determination of Q-value. Results of analysis for methods
were tested and validated for various parameters according
to ICH guidelines, hence can be adopted for the routine
analysis of Esomeprazole and Itopride in tablet dosage form.
The proposed method is new, accurate, simple and economic.
KEYWORDS:
Hydrotropic Solubilization, Esomeprazole, Itopride,
Simultaneous equation method, Absorbance ratio method.
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