Development and validation of RP-HPLC method for determination of Duloxetine hydrochloride in bulk and dosage form

Abstract

A reverse phase high performance liquid chromatographic method was developed for the determination of duloxetine hydrochloride in bulk and dosage form. The separation was effected on a kromasil ODS C18 column (250mmX4.6mm, 5?) using a mobile phase mixture of buffer and methanol in a ratio of 85:15 v/v at a flow rate of 1.0ml/min. The detection was made at 230nm. The retention time of duloxetine hydrochloride was found to be 3.443±0.06 min. Calibration curve was linear over the concentration range of 20-120?g/ml of duloxetine hydrochloride. The propose method was validated as per the ICH guidelines. The method was accurate, precise, specific and rapid found to be suitable for the quantitative analysis of the drug and dosage form.DOI: http://dx.doi.org/10.3329/icpj.v1i5.10281International Current Pharmaceutical Journal 2012, 1(5): 98-102

Development and validation of an analytical method for the stability of duloxetine hydrochloride

“…Samples were withdrawn at appropriate times and analysed by HPLC after suitable dilution [7,[24][25][26][27]. Peak purity and mass balance were monitored for each degradation condition.…”

“…Various analytical methods have been reported namely, HPLC [10][11][12][13][14][15][16][17], high-performance thin-layer chromatography [18,19], ultra-performance liquid chromatography [20] and liquid chromatography-tandem mass spectrometry [21][22][23]. Degradation studies have also been reported [24][25][26][27] under thermal, acidic, alkaline, neutral hydrolysis and oxidative photolytic stress conditions.…”

Characterization of stress degradation products of mirabegron using UPLC-QTOF-MS/MS and in silico toxicity predictions of its degradation products

“…Mirabegron binds with beta-3 adrenoreceptors and has been shown to decrease the muscle contractions. A thorough literature search revealed that RP-HPLC method for pharmaceutical dosage form, 6 GC method for residual solvent analysis 7 and one bioanalytical method has been reported for the determination of MIR in the human plasma by LC-MS/MS for clinical pharmacokinetic study. 8 To the best of our information, a comprehensive stress degradation study has not been reported so far.…”

Zirconium Oxide Nanostructure Integrated Screen-Printed Mirabegron Voltammetric Sensors

“…However, several analytical research approaches have been reported for assaying of MIR in biological fluids, synthetic matrices, or pharmaceutical dosages. Examples of such analytical methods included HPLC, 13 RP-HPLC, [14][15][16][17] UPLC, 18,19 UHPLC, 20 LC-MS, and LC-MS/MS, [21][22][23] HPTLC, 24 and TLC plates. 25 Nevertheless, UV spectrophotometric [26][27][28][29] and spectrofluorimetric methods 30 were also reported.…”