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Estimation of Duloxetine Hydrochloride in Pharmaceutical Formulations by RP-HPLC Method.

Patel SK, Patel NJ, Patel KM, Patel PU, Patel BH - Indian J Pharm Sci (2008)

Bottom Line: The retention time was 5.61 min.The linearity curve was found to be linear over 0.25-4 μg/ml.The limit of detection and limit of quantification were found to be 0.10 and 0.25 μg/ml respectively.

View Article: PubMed Central - PubMed

Affiliation: S. K. Patel college of Pharmaceutical Education and Research, Ganpat University, Kherava-382 711, India.

ABSTRACT
Simple, specific, accurate and precise method, namely, reverse phase high performance liquid chromatography was developed for estimation of duloxetine HCl in pharmaceutical formulations. For the high performance liquid chromatography method, Phenomenox C-18, 5 μm column consisting of 250×4.6 mm i.d. in isocratic mode, with mobile phase containing 0.01M 5.5 pH phosphate buffer: acetonitrile (60:40 v/v) and final pH adjust to 5.5±0.02 with phosphoric acid was used. The flow rate was 1.2 ml/min and effluent was monitored at 231 nm. The retention time was 5.61 min. The method was validated in terms of linearity, accuracy and precision. The linearity curve was found to be linear over 0.25-4 μg/ml. The limit of detection and limit of quantification were found to be 0.10 and 0.25 μg/ml respectively. The proposed method was successfully used to determine the drug content of marketed formulations.

No MeSH data available.


Chromatogram of duloxetine hydrochlorideHPLC peak showing a retention time of 5.61 corresponding to duloxetine at λ 231 nm
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Figure 0001: Chromatogram of duloxetine hydrochlorideHPLC peak showing a retention time of 5.61 corresponding to duloxetine at λ 231 nm

Mentions: To optimize the HPLC parameters, several mobile phase compositions were tried. Satisfactory peak symmetry was obtained with mobile phase consisting of phosphate buffer (5.5 pH):acetonitrile (60:40 v/v) and final pH adjusted to 5.5±0.02 with phosphoric acid. Quantification was achieved with UV detection at 231 nm based on peak area. A representative chromatogram is shown in fig. 1. Parameters of chromatogram are shown in Table 1.


Estimation of Duloxetine Hydrochloride in Pharmaceutical Formulations by RP-HPLC Method.

Patel SK, Patel NJ, Patel KM, Patel PU, Patel BH - Indian J Pharm Sci (2008)

Chromatogram of duloxetine hydrochlorideHPLC peak showing a retention time of 5.61 corresponding to duloxetine at λ 231 nm
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC3040888&req=5

Figure 0001: Chromatogram of duloxetine hydrochlorideHPLC peak showing a retention time of 5.61 corresponding to duloxetine at λ 231 nm
Mentions: To optimize the HPLC parameters, several mobile phase compositions were tried. Satisfactory peak symmetry was obtained with mobile phase consisting of phosphate buffer (5.5 pH):acetonitrile (60:40 v/v) and final pH adjusted to 5.5±0.02 with phosphoric acid. Quantification was achieved with UV detection at 231 nm based on peak area. A representative chromatogram is shown in fig. 1. Parameters of chromatogram are shown in Table 1.

Bottom Line: The retention time was 5.61 min.The linearity curve was found to be linear over 0.25-4 μg/ml.The limit of detection and limit of quantification were found to be 0.10 and 0.25 μg/ml respectively.

View Article: PubMed Central - PubMed

Affiliation: S. K. Patel college of Pharmaceutical Education and Research, Ganpat University, Kherava-382 711, India.

ABSTRACT
Simple, specific, accurate and precise method, namely, reverse phase high performance liquid chromatography was developed for estimation of duloxetine HCl in pharmaceutical formulations. For the high performance liquid chromatography method, Phenomenox C-18, 5 μm column consisting of 250×4.6 mm i.d. in isocratic mode, with mobile phase containing 0.01M 5.5 pH phosphate buffer: acetonitrile (60:40 v/v) and final pH adjust to 5.5±0.02 with phosphoric acid was used. The flow rate was 1.2 ml/min and effluent was monitored at 231 nm. The retention time was 5.61 min. The method was validated in terms of linearity, accuracy and precision. The linearity curve was found to be linear over 0.25-4 μg/ml. The limit of detection and limit of quantification were found to be 0.10 and 0.25 μg/ml respectively. The proposed method was successfully used to determine the drug content of marketed formulations.

No MeSH data available.