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THE PHARMA REVIEW (MARCH - APRIL 2011)

Application of Mixed Hydrotropic Solubilization Phenomenon for
Quantitative Analysis of Olmesartan Medoxamil in Tablet

Nilesh Jain*, Ruchi Jain, Hemendra K. Sharma, Deepak K. Jain# and Surendra K. Jain

Abstract: A novel, accurate, economic and safe UV spectrophotometric method has been developed for determination of Olmesartan Medoxamil by application of mixed hydrotropy phenomena. These method using a mixture of 2 M sodium acetate and 8 M Urea solution (50:50% V/V) as hydrotropic solubilizing agent to solubelize poorly water soluble Olmesartan Medoxomil (solubility:- 7.75e-03 mg/mL in water) from tablet dosage form. The solubility of Olmesartan Medoxomil increases in 44 times mixed hydrotropic solution as compared to solubilities in distilled water. Olmesartan Medoxomil shows maximum absorbance at 257nm. Sodium acetate, urea, and other tablets excipents did not show any absorbance above 240 nm, and thus no interference in the estimation was seen. Olmesartan medoxomil was obeyed lamberts Beer’s law linear in the concentration range of 10 to 50μg/ml with correlation coefficient (r2= 0.9997). The mean percent claim from tablet was found to be 96.540.59%. The method was found to be precise, simple, economic, safe, rapid, accurate and validated as per ICH guidelines and can be used for determination of Olmesartan Medoxomil in tablet formulations.
Introduction
Olmesartan Medoxomil (OLM)1 [2,3-dihydroxy-2-butenyl 4-(1-hydroxy-1-methylethyl)-2-propyl-1-[p-(o-1H-tetrazol-5-ylphenyl)benzyl]imidazole-5-carboxylate, cyclic 2,3-carbonate.] is an angiotensin II receptor blocker (ARB). Olmesartan blocks the vasoconstrictor effects of angiotensin II by selectively blocking the binding of angiotensin II to the AT1 receptor in vascular smooth muscle. Olmesartan medoxomil, a prodrug, is hydrolyzed to olmesartan during absorption from the gastrointestinal tract having absolute bioavailability of 26% and half-life of about 13 hours2, 3. Hydrotropic solubilization is the phenomena by which aqueous solubility of poorly water-soluble drugs and insoluble drugs increases. Literature survey reveals that various poorly water-soluble drugs was analyzed by using hydrotropic solubilization phenomenon viz. salicylic acid4, ketoprofen5, frusemide6, cefixime7, tinidazole8, piroxicam9. hyrochlorthiazide10,11, norfloxacin12, aspirin13, NSAIDs14, torsemide15. Several analytical methods that have been reported for the estimation of Olmesartan Medoxomil include UV-Vis spectrophotometry16, high-performance liquid chromatography (HPLC)17, high-performance thin layer chromatography (HPTLC)18 and tandam mass spectroscopy19 However there is no method available for the determination of these OLM by using hydrotropic agent. Therefore, an attempt was made to develop a new, rapid and sensitive method for the quantitation of OLM in tablet dosage form by using mixed hydrotropic solubilization phenomena. To access the reproducibility and wide applicability of .

 

 

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