Simultaneous HPLC Analysis of Olmesartan and Hydrochlorothiazide in Combined Tablets and in vitro Dissolution Studies |
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Authors: | O Sagirli A Önal S E Toker D ?ensoy |
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Institution: | (1) Faculty of Pharmacy, Department of Analytical Chemistry, Istanbul University, 34116 Istanbul, Turkey;(2) Faculty of Pharmacy, Department of Pharmaceutical Technology, Istanbul University, 34116 Istanbul, Turkey |
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Abstract: | A simple, rapid and reproducible HPLC method was developed and validated for the simultaneous determination of olmesartan
(OLM) medoxomil and hydrochlorothiazide (HCT) in combined tablets. Chromatography was carried out on a 4.6 mm I.D × 200 mm,
5 μm cyano column with methanol–10 mM phosphoric acid containing 0.1% triethylamine (pH 2.5, 50:50 v/v) at a flow rate of 1.0 mL min−1 and UV detector was set at 260 nm. Valsartan (VAL) was used as internal standard (IS). A linear response was observed in the
range of 0.2–6 μg mL−1 (r
2 = 0.9998) for OLM and 0.1–4 μg mL−1 (r
2 = 0.9999) for HCT, respectively. The method showed good recoveries (99.56% for OLM and 99.48% for HCT) and the relative standard
deviation (RSD) values for intra- and inter-day precision were 0.70–1.59 and 0.80–2.00% for OLM and 1.20–1.37 and 1.63–1.93%
for HCT, respectively. The developed method was applied successfully for quality control assay of OLM and HCT in combined
tablets and in vitro dissolution studies. |
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Keywords: | Column liquid chromatography Dissolution studies Validation and quality control Olmesartan and hydrochlorothiazide |
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