International Journal of Pure and Applied Chemistry (IJPAC)

 

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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