A Validated Chiral Rp-HPLC Method for the Enantiomeric Separation of Duloxetine Hydrochloride Using Chiral-Agp as the Stationary Phase

Davadra, Prakash M.; Patel, S. R.; Jain, Mukul; Patel, Pankaj; Joshi, H. S.; Bapodra, Atul H.

doi:10.1080/10826076.2011.578322

Cited by 3 publications

(3 citation statements)

References 22 publications

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“…Table 2 summarizes the values for retention factor (k), separation factor (α), and resolution (R s ) for the diastereomeric derivatives separated under the optimized HPLC conditions. Resolution parameters of diastereomeric derivatives show superiority of the present method, particularly over chiral HPLC, in terms of higher resolution value (Davadra et al, 2011;Rane & Shinde, 2008;Yang et al, 2007). As reported earlier (Nagar et al, 2020), MeCN provided a higher elution power than MeOH in RP chromatography.…”

Section: Separation By Hplc and Determination Of Enantiomeric Puritysupporting

confidence: 73%

“…Direct separation of enantiomers of Dul has been performed by HPLC using certain chiral stationary phases (Davadra et al, 2011;Rane & Shinde, 2008;Valimaña-Traverso et al, 2019;Xu et al, 2010;Yang et al, 2007). The advantages of using chiral derivatizing reagents (CDRs) in the solution of practical problems in pharmaceutical and biomedical analyses include easy optimization of chromatographic conditions, excellent detection due to chromophoric or fluorophoric properties of CDR, and the prospects of using low-cost achiral columns in comparison to highly expensive chiral columns (Bhushan & Martens, 2010;Malik & Bhushan, 2017).…”

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confidence: 99%

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Reversed‐phase‐HPLC enantioseparation and control of enantiomeric purity of duloxetine using a new chiral reagent and recovery of enantiomers

Vyas

Bhushan

Nagar

et al. 2021

Biomedical Chromatography

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This study reports a rapid and low-cost LC method for control of enantiomeric purity of duloxetine. Though duloxetine, as marketed and administered, is expected to be a single (S)-enantiomer, the analysis of a few commercial branded samples by the method developed and presented here showed that they contain a relatively high percentage of (R)-enantiomer (e.g., 2.71-5.42%, which is undesirable in drug formulations). A new chiral derivatizing reagent [isatinyl-(S)-naproxen amide] was synthesized on (S)-naproxen platform. Diastereomeric derivatives were synthesized under microwave irradiation and were separated using reversed-phase-HPLC on a C 18 column. A combination of acetonitrile and triethylammonium phosphate buffer (9 mM, pH 4) as the mobile phase and detection at 273 nm were found successful. The diastereomeric derivatives at preparative scale were separated using open column chromatography, and the native enantiomers were obtained and characterized. The HPLC separation method was validated for detection limit, linearity, accuracy, and precision. The limits of detection of (S,R)-diastereomer and (S,S)-diastereomer were found to be 12 and 16 pg/mL, respectively, for the 20-μL injected volume. The method so developed has a practical significance and greater societal impact in establishing the control of enantiomeric purity and in ensuring the enantiomeric purity of the drug meant for human consumption.

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Section: Separation By Hplc and Determination Of Enantiomeric Puritysupporting

confidence: 73%

mentioning

confidence: 99%

Reversed‐phase‐HPLC enantioseparation and control of enantiomeric purity of duloxetine using a new chiral reagent and recovery of enantiomers

Vyas

Bhushan

Nagar

et al. 2021

Biomedical Chromatography

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“…LOD and LOQ for R ‐DLX were 150 and 450 ng mL −1 , respectively. The method was applied for the determination of enantiomeric purity of S ‐DLX in bulk drug and pharmaceutical preparations (Davadra et al, 2011).…”

Section: Introductionmentioning

confidence: 99%

Achiral and chiral analysis of duloxetine by chromatographic and electrophoretic methods, a review on the separation methodologies

Lupu

Hancu

2020

Biomedical Chromatography

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Duloxetine (DLX) is a widely used antidepressant drug belonging to the class of selective serotonin and norepinephrine reuptake inhibitors (SNRIs); its efficacy has been demonstrated in the treatment of not only major depressive disorders but also diabetic neuropathic pain, generalized anxiety disorder, fibromyalgia or stress urinary incontinence. It is a chiral substance and is used in therapy in the form of the enantiopure S-DLX, which is twice as active as R-DLX. Several methods have been published for the achiral and chiral determination of DLX in pharmaceuticals, biological materials and environmental samples, the majority using liquid chromatography and capillary electrophoresis coupled with different detection techniques (UV detection, fluorescence, mass spectrometry). The aim of the current review is to provide a systematic survey of the analytical techniques used for the determination of DLX from different matrices.

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Chiral Chromatography and Determination of Chiral Molecules: Past, Present, and Future Perspectives

Chandarana¹,

Rejji²

2023

J Anal Chem

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A Validated Chiral Rp-HPLC Method for the Enantiomeric Separation of Duloxetine Hydrochloride Using Chiral-Agp as the Stationary Phase

Cited by 3 publications

References 22 publications

Reversed‐phase‐HPLC enantioseparation and control of enantiomeric purity of duloxetine using a new chiral reagent and recovery of enantiomers

Reversed‐phase‐HPLC enantioseparation and control of enantiomeric purity of duloxetine using a new chiral reagent and recovery of enantiomers

Achiral and chiral analysis of duloxetine by chromatographic and electrophoretic methods, a review on the separation methodologies

Chiral Chromatography and Determination of Chiral Molecules: Past, Present, and Future Perspectives

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