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Page 1: Simultaneous RP-HPLC analysis of atenolol, hydrochlorothiazide, and losartan potassium in a tablet formulation

Acta Chromatographica 22(2010)2, 219–226 DOI: 10.1556/AChrom.22.2010.2.5

0231–2522 © 2010 Akadémiai Kiadó, Budapest

Simultaneous RP-HPLC Analysis of Atenolol, Hydrochlorothiazide, and Losartan Potassium

in a Tablet Formulation

A.B. THOMAS*, U.B. CHAVAN, R.K. NANDA, L.P. KOTHAPALLI, S.N. JAGDALE, S.B. DIGHE, AND A.D. DESHPANDE

Department of Pharmaceutical Chemistry, Padm Dr D.Y. Patil Institute of

Pharmaceutical Sciences and Research, Pimpri, Pune-411018, Maharashtra, India E-mail: [email protected]

Summary. Simultaneous analysis of atenolol (Atn), hydrochlorothiazide (Hctz) and losartan potassium (Los) in solid dosage forms has been achieved by reversed-phase high-performance liquid chromatography on a C18 column with a 0.035 M potassium di-hydrogen orthophosphate–acetonitrile gradient as mobile phase and UV detection at 225 nm. The retention times for Atn, Hctz, and Los were 2.91, 4.75, and 7.52 min, respec-tively, with mean recoveries of 99.67, 99.89, and 100.69%. The method was validated in accordance with ICH guidelines. Because of its simplicity and high precision and accu-racy, the method can be used for analysis of atenolol, hydrochlorothiazide and losartan potassium in pharmaceutical preparations. Key Words: atenolol, hydrochlorothiazide, losartan, HPLC

Introduction Atenolol [Atn; (R,S)-4-(2-hydroxy-3-isopropylaminopropoxy) phenylaceta-mide] is a β-blocker which is official in IP, BP, and USP [1–3]. Hydro-chlorothiazide (Hctz; 6-chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide-1,1-dioxide) is a diuretic official in IP and BP [1, 2]. Losartan [Los; 1-((2′-(2H-tetrazol-5-yl)biphenyl-4-yl)methyl)-2-butyl-4-chloro-1H-imi-dazol-5-yl)methanol] is an angiotensin II inhibitor that is official in IP and USP [1, 3]. A combination of these drugs is used for treatment of hyperten-sion. A fixed-dose combination of losartan–hydrochlorothiazide is a logical choice for antihypertensive treatment, including for initial therapy in pa-tients with elevated blood pressure. The renin–angiotensin–aldosterone sys-