International Journal of Pure and Applied Chemistry (IJPAC)

 

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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