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Article type: Research Article
Authors: Hashem, Hishama; b; * | Ibrahim, Adel Ehabb | Elhenawee, Magdaa
Affiliations: [a] Department of Pharmaceutical Analytical Chemistry, Faculty of Pharmacy, Zagazig University, Zagazig, Egypt | [b] Egyptian International Pharmaceutical Industries Co. “EIPICo”, Tenth of Ramadan City, Egypt
Correspondence: [*] Corresponding author: Dr. Hisham Hashem, Department of Pharmaceutical Analytical Chemistry, Faculty of Pharmacy, Zagazig University, Zagazig, Egypt and Egyptian International Pharmaceutical Industries Co. “EIPICo”, Tenth of Ramadan City, Egypt. Tel./Fax: +20552303266; E-mail: [email protected].
Abstract: A simple, rapid and accurate, routine-LC method is described for simultaneous determination of four antihypertensive drugs, hydrochlorothiazide, losartan potassium, valsartan and irbesartan in bulk powders and pharmaceutical preparations. The chromatographic separation of the four pharmaceuticals was achieved on a reversed phase C18 “Intersil® ODS-3” column (5 μm, 4.6×250 mm) using a binary mobile phase of 45% ACN and 55% 50 mM KH2PO4 (pH 4.5) at 1 mL/min flow rate. The detection-wavelength was 210 nm. The total separation time was less than 12 min. The method was validated for system efficiency, linearity, accuracy, precision, limits of detection and quantitation, specificity, stability and robustness. The limits of detection were 0.02, 0.12, 0.14 and 0.01 μg/mL for hydrochlorothiazide, losartan potassium, valsartan and irbesartan, respectively. Linearity ranges were 5–50 μg/mL for hydrochlorothiazide, 10–100 μg/mL for losartan potassium, irbesartan and valsartan. The recovery values of this method were between 97 and 103% and the reproducibility was within 1.67%. Statistical analysis proved that the method enabled reproducible and selective quantification of all four analytes as the bulk drug and in pharmaceutical preparations.
Keywords: HPLC, simultaneous determination, antihypertesives, pharmaceutical preparations
DOI: 10.3233/MGC-160213
Journal: Main Group Chemistry, vol. 15, no. 4, pp. 335-346, 2016
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