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RP-LC Determination of Atomoxetine HCl from its Pharmaceutical Dosage Form

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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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Acknowledgment

The authors are thankful to Dr. Arvind A. Natu (Sr. Scientist, NCL, Pune), Dr. Lalit Anande, Dr. Ashok Mehta and Prof. Dr. R.T. Sane for their valuable guidance and cooperation.

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Authors and Affiliations

  1. Therapeutic Drug Monitoring Laboratory, 194, Scheme No. 6, Road No.15, Sion Koliwada, Sion (E), Mumbai, 400 022, India

    Sudhir S. Kamat, Vishal B. Choudhari, Vinayak T. Vele & Swarup S. Prabhune

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  1. Sudhir S. Kamat
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  2. Vishal B. Choudhari
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  3. Vinayak T. Vele
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  4. Swarup S. Prabhune
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Correspondence to Swarup S. Prabhune.

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Kamat, S.S., Choudhari, V.B., Vele, V.T. et al. RP-LC Determination of Atomoxetine HCl from its Pharmaceutical Dosage Form. Chroma 67, 143–146 (2008). https://doi.org/10.1365/s10337-007-0444-y

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  • DOI: https://doi.org/10.1365/s10337-007-0444-y

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