Validated LC Method, with a Chiral Mobile Phase, for Separation of the Isomers of Fexofenadine Hydrochloride |
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Authors: | Arvind A. Sakalgaonkar Sunil R. Mirgane R. P. Pawar |
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Affiliation: | (1) Therapeutic Drug Monitoring Laboratory, 194, Scheme No. 6, Road No.15, Sion Koliwada, Sion (E), Mumbai, 400 022, India |
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Abstract: | A rapid, simple and sensitive high-performance liquid chromatographic method (HPLC) has been developed to assay atomoxetine HCl in capsules. The HPLC analysis used a reversed phase C18 (150 × 4.6 mm i.d. 5 μm particle size) analytical column and a mobile phase consisting of monobasic potassium dihydrogen orthophosphate and acetonitrile (95:5 v/v), with UV detection at 269 nm. The validation data showed that the assay is sensitive, specific and reproducible for determination of atomoxetine HCl in this dosage form. Calibration curves were linear from 1 to 10 μg mL−1 (R 2 > 0.997). The accuracy of the method ranged from 98.13 to 101.5%. Mean inter- and intra-assay relative standard deviations (RSD) were less than 1.0%. The proposed method provided an accurate and precise analysis of atomoxetine HCl in its pharmaceutical dosage form. |
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Keywords: | Column liquid chromatography Pharmaceutical formulation Atomoxetine HCl |
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