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L. Bhaskar Reddy et al., IJSID 2011, 1 (1), 33-40INTRODUCTIONLosartan Potassium (1-3) , 2-butyl-4-chloro-1-[[2’-(1H-tetrazol-5-yl) [1, 1’-biphenyl]-4-yl] methyl]-1Himidazole- 5-methanol mono Potassium salt. It is the first member of a new class of nonpeptideangiotensin II receptor antagonist. It is used to treat hypertension by suppressing the effects ofangiotensin II at its receptors, thereby blocking the renin-angiotensin system. Losartan has beendemonstrated to be superior to previous peptide receptor antagonists and angiotensin convertingenzyme inhibitors because of its enhanced specificity, selectivity, and tolerability. Losartan potassium ismarketed alone or combined with hydrochlorothiazide.Hydrochlorothiazide (HCTZ) (4, 5) is a thiazide class diuretic drug. This reduces the volume of theblood, decreasing blood return to the heart. Hydrochlorothiazide is often used in the treatment ofhypertension, congestive heart failure, symptomatic edema and the prevention of kidney stones. Therecommended dose of hydrochlorothiazide for treating high blood pressure is hydrochlorothiazide 25 mgto 50 mg per day.Enalapril maleate (6-8) is used to treat high blood pressure (hypertension), it works by relaxingblood vessels, causing them to widen. Lowering high blood pressure helps prevent strokes, heart attacksand kidney problems. Enalapril maleate is supplied as 2.5 mg, 5 mg, 10 mg, and 20 mg tablets for oraladministration. Side effects are light-headed, fainting and urinating more or less than usual, fever, chills,body aches, flu symptoms, pale skin, easy bruising or bleeding. Figure-1 represents the chemicalstructure of three active ingredients.Losartan Potassium Hydrochlorothiazide Enalapril MaleateFigure-1: Chemical structure of Three active ingredientsThe literature reports many analytical methods were reported for the quantization of Losartanand hydrochlorothiazide in tablets using HPLC and methods for enalapril maleate andhydrochlorothiazide formulations by HPLC and methods for enalapril maleate and Losartan by HPLC. TheInternational Journal of Science Innovations and Discoveries VOL1, Issue 1, July-August 201134
L. Bhaskar Reddy et al., IJSID 2011, 1 (1), 33-40purpose of this study was to develop a single RP-HPLC method for the estimation of Losartan Potassium,enalapril maleate and hydrochlorothiazide simultaneously.MATERIALS AND METHODSMaterials: All the chemicals and solvents used were of AR. The pure drugs Losartan Potassium, enalaprilmaleate and hydrochlorothiazide were used as standards. All market samples were procured and usedfor this study.Standard Solution: Prepared the standard solution to get the known concentration of all activeingredients 70ppm with diluent.Chromatographic conditions:The following Chromatographic conditions were established for separation of active samples fromall its degradation products and maintained throughout the method.Column:Intersil C18, 250 mm x 4.6 mm, 5 μMobile phase Methanol: ACN: Water: 0.1% ortho-phosphoric acid (35:5:5:5% v/v/v/v), with pHto 3.0 with triethylamine.Detection: wavelength 230nmSample size: 20μL.Temperature: Room temp.Run time: 8min.Flow rate: 1.0ml per minAnalysis of Marketed Formulation: All market samples were prepared to get known concentration ofall active ingredients 70ppm with diluent.RESULTS AND DISCUSSIONMethod development:Method development trials were performed with a C18 column and a mobile phase containingacetonitrile and water in 60:40 proportions and tried with changing the proportion of organic solventswere studied. Acetonitrile, methanol, phosphate buffer and water in various ratios were tested to get anappropriate mobile phase composition. The mixtures of acetonitrile, methanol and water at various ratioswere examined, which resulted in very close retention times of the peaks. Best resolution was achievedwith the mobile phase having composition of Methanol: ACN: Water: 0.1% ortho-phosphoric acid(35:5:5:5% v/v/v/v) with pH to 3.0 with triethylamine. Figure-2 represents the individual injections ofthree actives.International Journal of Science Innovations and Discoveries VOL1, Issue 1, July-August 201135
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