Novel Spectrophotometric Method for Estimation of Olmesartan Medoxomil from its Tablet Dosage Form Using Hydrotropic Solubilization
Keywords:
Olmesartan Medoxomil, Hydrotropy, Sodium acetate spectrophotometric EstimationAbstract
Aim: Quantitative estimation of poorly water-soluble drugs involves use of organic solvents. In the present investigation, hydrotropic solubilization is employed to enhance the aqueous solubilities of poorly water-soluble drugs like Olmesartan Medoxomil in tablet dosage forms.
Material and methods: This method utilizes 0.05 M Sodium acetate solution as hydrotropic solubilizing agent Where Olmesartan Medoxomil shows maximum absorbance at 256 nm. The 0.05 M Sodium acetate solution does not show any interference with the sampling wavelength. The hydrotropic agent and additives used in the manufacture of tablets did not interfere in the analysis.
Results and Conclusion: The drug obeys the Beer’s Law in the concentration range 2-14 μg/ml with correlation coefficient value of 0.9987. The developed reliable method was validated statistically following ICH Q2B (R1) guidelines. Statistical analysis proved that the method was simple and rapid for the estimation of Olmesartan Medoxomil and can be used for routine analysis of Olmesartan Medoxomil in quality control laboratories. The ex vivo mucoadhesion time of patches ranged between 109 min (FA10) to 126 min (FB14). The ex vivo mucoadhesive force was in the range of 0.278 to 0.479 Kg.m.s-2. The in vitro drug release studies revealed that formulation FA8 released 84% and FB16 released 99.01% of drug in 140 min.
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References
Norwood D, Branch E, Smith B, Honeywell M. Olmesartan Medoxomil for hypertension: a clinical review, drug forecast. Pharmacology and Therapeutics. 27(12)2009; 611.
Schwocho LR, Masonson HN. Pharmacokinetics of CS-866. a New Angiotensin I receptor blocker. In healthy subjects. J Clin Pcol. 2001; 41:515-27.
Chrysant SG, Weber MA, Wang AC, Himman DJ. Evaluation of Antihypertensive therapy with the combination of olmesartan medoxomil and hydrochlorothiazide. Am J Hypertens J of amjhyper. 2003;8:11-23.
Marshall TG, Lee RE, Marshall FE. Common angiotensin receptor blockers may directly modulate the immune system via VDR, PPAR and CCR2b. J Pharm Exp Ther. 1989;2:806–15.
Verma PK, Kamboj VK, Ranjan SD. Spectrophotometric estimation of olmesartan medoxomil in tablet dosage form with stability studies. Chem Tech. 2010; 6:1129-34.
Patil P, Barge V, More H, Piswikar S. Spectrophotometeric method for simultaneous determination of olmesartan medoxomil and amlodipine besylate from tablet dosage form. Int J Cur Pharm Res. 2011; 3:74-9.
Murakami T, Konno H, Fukutsu N. Identification of a degradation product in stressed tablets of olmesartan medoxomil by the complementary use of HPLC hyphenated techniques. J Pharm Biomed Anal. 2008; 4:1-7.
Celebier M, Altinoz S. determination of olmesartan medoxomil in tablets by UV-Vis spectrophotometry. Pharmazie. 2007; 64:419-22.
Shah NJ, Suhagia BN. Development and validation of a simultaneous hptlc method for the estimation of olmesartan medoxomil and hydrochlorothiazide in tablet dosage form. Indian J Pharm Sci. 2007;69:834-836.
Mahaparale SP, Andhale YS, Sonawane VH. Simultaneous estimation of olmesartan medoxomil and hydrochlorothiazide in tablet dosage form by UV- spectrophotometric method. Int J Pharm Res Devlp. 2011;2:242–47.
Rochele BL, Rossi CR, Dias CL,Bergold AM, Fröehlich PE. Development and validation of a discriminating in vitro dissolution method for a poorly soluble drug. olmesartan medoxomil comparison between commercial tablets. AAPS Pharm Sci Tech. 2010; 11:637–44.
Sagirli O, Nall AO, Toker SE, Sensoy D. Simultaneous HPLC analysis of olmesartan and hydrochlorothiazide in combined tablets and in vitro dissolution studies. J Chromatographia. 2007; 66:213-18.
Jadhav SD, Bhatia MS, Thamake SL. Spectrophotometric methods for estimation of atorvastatin calcium from tablet dosage forms. Int J Pharm Tech Res. 2010; 2:1948-53.
Deepti M, Jain A, Maheshwari RK, Patidar V. Simultaneous spectrophotometric estimation of metronidazole and norfloxacin in combined tablet formulations using Hydrotropy. Res J Pharm Tech. 2008; 3:357-61.
Maheshwari RK, Novel spectrophotometric estimation of frusemide using hydrotropic solubilization phenomenon. Int J Pharm Sci. 2007; 4:822-24.
Chan CC. Analytical method validation and instrument performance verification. Wiley Interscience. 2004:16-22.
International conference on harmonization, ICH Q2B R1, Text on validation of analytical procedures. Geneva. 1994: 1-5.
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