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1. A validated NP – HPLC Method for the determination of formic acid in pharmaceutical excipient imidurea

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Author(s): Mubeen Ahmad Khan | Sukumar Sinha | Vikas Parashar | Nandkumar Khandekar | Sadanandam Bathini

Journal: International Journal of Pharmaceutical and Biomedical Research (IJPBR)
ISSN 0976-0350

Volume: 02;
Issue: 03;
Start page: 140;
Date: 2011;
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Keywords: Normal phase | HPLC method development | Formic acid | Imidurea | LOD | Method validation

ABSTRACT
A sensitive and specific normal phase high performance liquid chromatography (NP-HPLC) method with UV detection has been developed and validated for the quantification of formic acid in pharmaceutical excipient imidurea. The chromatographic separation was carried out on a Hypersil Silica 250 x 4.6 mm, 5µ (Thermo Electron Corporation, USA) with a flow rate of 0.5 mL/min and the column temperature was maintained at 30°C. The mobile phase consisted of n-hexane-isopropyl alcohol-trifluoroacetic acid (900:100:0.5, v/v/v). The samples were injected with an injection volume of 20 µL and detection was accomplished by a variable wavelength UV detector at 230 nm. The retention time of formic acid was about 8.9 min. The method was linear over the range of 331- 7500 µg/mL for formic acid with a correlation of 0.9928. The limit of detection and limit of quantification were 109 and 331 µg/mL respectively. The present method may be applicable for the detection of formic acid in different pharmaceutical product as well.
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