7. Simultaneous
Estimation and Validation of Poorly Water Soluble Drugs Rabeprazole
Sodium and Itropide Hydrochloride Combined Tablet Dosage Form by
Hydrotropic Solubilization Agents
S.Sharma1, R. Sharma, M.C. Sharma*
School of Pharmacy, Devi
Ahilya Vishwavidyalaya, Takshshila Campus, Khandwa Road, Indore (M.P)
452001, India
1 Department of Chemistry Yadhunath Mahavidyalya Bhind (M.P)
477001 India
* Corresponding Author: Mukesh Chandra Sharma, School of Pharmacy, Devi
Ahilya Vishwavidyalaya, Takshshila Campus, Khandwa Road, Indore- 452
001, Madhya Pradesh, India, Tel. : +91 731 2100605, E-mail:
mukeshcsharma@yahoo.com
Abstract:
Quantitative analysis of poorly water-soluble drugs involves use
of various organic solvents. Sodium benzoate is one of the
widely used hydrotropic agents and has demonstrated the
enhancement in aqueous solubilities of a large number of poorly
water-soluble drugs. In the present investigation 3.5 M sodium
benzoate solution has been used as hydrotropic solubilizing
agent for poorly water-soluble, Rabeprazole sodium and Itropide
Hydrochloride in combined dosage form. An ultraviolet (UV)
spectrophotometic method was developed and validated for
quantitative determination of the proposed method is based on
simultaneous equation method. The absorption maxima (λmax) of
Rabeprazole sodium and Itropide Hydrochloride were 271 nm and
306 nm respectively. The calibration curves were prepared. The
proposed method obeys Beers law in concentration range 5-35
µg/ml for Rabeprazole sodium and Itropide Hydrochloride
respectively with correlation coefficients were found to be
0.9999 and 0.9981 respectively. The method was contempt using
known concentration of drug and percentage recovery was found in
the range of 99 % to 105 %. Analyzing the combination in tablet
dosage form, recovery study showed a good agreement in the assay
of results. The proposed method is simple, precise, and accurate
and can be employed for routine analysis of Rabeprazole sodium
and Itropide Hydrochloride in tablet dosage form. The proposed
method was validated statistically by low values of statistical
parameters viz. standard deviation, percent coefficient of
variation and standard error. The proposed method is new,
accurate, simple and economic.
KEYWORDS:
Rabeprazole sodium, Itropide HCl, Simultaneous equation,
Derivative spectrophotometry method, AUC, Hydrotropic
Solubilization.
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