Simultaneous determination of fexofenadine and its related compounds by HPLC.
A simple reversed phase liquid chromatographic (RPLC) method has been developed and subsequently validated for the determination of fexofenadine hydrochloride and its related compounds A and B. The method utilizes a C8 column for the separation and determination of meta-isomer (related compound B). The separation was achieved using an Eclipse XDB C8, 5 microm, 4.6 x 150 mm column and a mobile phase comprising 1% triethylamine phosphate (pH 3.7), acetonitrile and methanol in the ratio 60:20:20 (v/v/v). 5-Methyl 2-nitrophenol has been used as internal standard for the purpose of quantitation of fexofenadine. The described method was linear over a range of 0.7-18.7 microg/ml for related compounds A and B and 60-750 microg/ml for assay of fexofenadine. The relative standard deviation (n=3) was 0.5% for the drug and 3.4% for related compounds. The intermediate precision was 0.79% (n=9) for assay and 5.16% (n=9) for related impurities. The mean recovery of both the related compounds were in the range of 94-103%. Limits of detection (LOD) and quantification (LOQ) for the related compounds A and B were 0.18, 0.12 and 0.56, 0.48 microg/ml, respectively. The precision of the method was checked by F-test using a reported method as reference and the calculated value (1.35) was found to be less than the table value at 95% confidence levels. The obtained results confirm that the method is highly suitable for its intended purpose.
Radhakrishna
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Department of Analytical Research, Dr. Reddy's Research Foundation, Miyapur, 500 050, Hyderabad, India.
Om Reddy
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D002214:Capsules; D002851:Chromatography, High Pressure Liquid; D004340:Drug Contamination / Q000517:prevention & control; D004355:Drug Stability; D006634:Histamine H1 Antagonists / Q000032:analysis*; D012680:Sensitivity and Specificity; D013607:Tablets; D016593:Terfenadine / Q000031:analogs & derivatives* / Q000032:analysis*
D002214:Capsules; D006634:Histamine H1 Antagonists; D013607:Tablets; D016593:Terfenadine; C093230:fexofenadine