Estimation of duloxetine hydrochloride in pharmaceutical formulations by RP-HPLC method_calibration analytical balance Sartorius

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Estimation of duloxetine hydrochloride in pharmaceutical formulations by RP-HPLC method

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niazi-pharmaceuticalinfo 2009-05-04 11:31:47 Publish:

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 m 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 g/ml. The limit of detection and limit of quantification were found to be 0.10 and 0.25 g/ml respectively. The proposed method was successfully used to determine the drug content of marketed formulations.

Keywords: Duloxetine HCl, isocratic mode, RP-HPLC, SSNRI
Duloxetine HCl (DLX) is chemically, 2(+)-(S)-N-methyl-(gamma)-(1-naphthyloxy)-2 thiophenepropylamine hydrochloride [1] . Duloxetine hydrochloride is a newer selective serotonin and norepinephrine reuptake inhibitor (SSNRI) used for major depressive disorders [2],[3] . Duloxetine is not official in any pharmacopoeia. A few methods in literature were reported for the determination of DLX and its key intermediate, desmethyl duloxetine in human serum by HPLC method [4],[5] . Literature reported the characterization of phenolic impurities in duloxetine HCl samples by MS, NMR, X-ray-analysis [6] and impurities formed by interaction of duloxetine HCl with various enteric polymers [7] . Simple UV Spectrophotometric method for estimation of duloxetine in formulation [8] is reported but calibration range is from 5-50 g/ml that shows the method is less sensitive. The present investigation describes a simple, rapid and reproducible RP-HPLC method with a calibration range of 0.25-4 g/ml for duloxetine HCl in capsule dosage form that is more appropriate for routine analysis.

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