10.
Quantitative Estimation and Validation with Using Hydrotropic
Solubilization Phenomenon in Pharmaceutical Combined tablet dosage
forms Atorvastatin calcium and Fenofibrate
Smita
Sharma1, Mukesh Chandra Sharma2*
1
Department of Chemistry Yadhunath Mahavidyalya Bhind (M.P) 477001
India
2* 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:
Attempting to minimize these drawbacks, three new, simple,
accurate, environmental friendly, cost effective, safe,
sensitive spectrophotometric methods have been developed for
simultaneous estimation of Atorvastatin calcium and Fenofibrate
in tablet dosage form using 7.0 M sodium benzoate aqueous
solution, 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
Atorvastatin calcium and Fenofibrate in 7.0 M sodium benzoate
solution respectively. Sodium benzoate solution and additives of
tablet did not interfere in analysis, as sodium benzoate did not
show any absorbance above 316 nm. In 7.0M sodium benzoate
solution, Atorvastatin calcium and Fenofibrate 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 Atorvastatin calcium and
5-40µg/ml for Fenofibrate. 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 Atorvastatin calcium and
Fenofibrate in tablet dosage form. The proposed method is new,
accurate, simple and economic.
Keywords: Hydrotropic Solubilization, Atorvastatin calcium
Fenofibrate, Simultaneous equation method, Absorbance ratio
method.
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