Simultaneous HPLC analysis of olmesartan and hydrochlorothiazide in combined tablets and in vitro dissolution studies


Sagirli O. , Oenal A., Toker S. E. , Şensoy D.

CHROMATOGRAPHIA, vol.66, pp.213-218, 2007 (Journal Indexed in SCI) identifier identifier

  • Publication Type: Article / Article
  • Volume: 66
  • Publication Date: 2007
  • Doi Number: 10.1365/s10337-007-0304-9
  • Title of Journal : CHROMATOGRAPHIA
  • Page Numbers: pp.213-218
  • Keywords: column liquid chromatography, dissolution studies, validation and quality control, olmesartan and hydrochlorothiazide, PERFORMANCE LIQUID-CHROMATOGRAPHY, TANDEM MASS-SPECTROMETRY, PARKINSONS-DISEASE, LOSARTAN POTASSIUM, CABERGOLINE, PLASMA, HYDROCHLORIDE, DIURETICS, AMILORIDE, PRODUCTS

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.

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 outon a 4.6 mm LD x 200 mm, 5 pm cyanocolumn 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 mu g mL(-1) (r(2) = 0.9998) for OLM and 0.1-4 pg 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.