New Simple Uv Spectrophotometric Method for Determination of Venlafaxine Hydrochloride in Pure and Pharmaceutical Formulation

Eswarudu, M.M.

doi:10.20959/wjpps20177-9541

Cited by 2 publications

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“…The VEN drug is available as a racemic mixture of the (−) R and (+) S-enantiomer. While in literature survey exposed that approximately UV methods [3][4][5][6][7][8] and RP-HPLC methods [9][10][11][12][13] are described for the determination of impurities 1-[Cyano-(4-methoxyphenyl) methyl] cyclohexanol,1-[2-Amino-1-(4-methoxyphenyl) ethyl] cyclohexanol hydrochloride, O-Desmethyl, and N-Desmethyl Venlafaxine content in VEN•HCl API and dosage form 14 . The RP-HPLC method developed by R.…”

Section: Introductionmentioning

confidence: 99%

RP-HPLC Method for Content of Genotoxic 4-methoxybenzyl Chloride in Venlafaxine

Khadangale,

Dhalape,

Pinjari

2023

Orient. J. Chem

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Venlafaxine, primarily available in dosage in Venlafaxine hydrochloride (VEN∙HCl) form, is a discriminating serotonin and norepinephrine reuptake inhibitor (SNRI) anti-depressant drug. The 4-methoxybenzyl chloride (4-MBC) is a genotoxic impurity present in VEN∙HCl. A reverse-phase high-performance liquid chromatography (RP-HPLC) method is developed for the determination of 4-MBC content this method is validated employing ICH (International Council on Harmonisation) guidelines. During the method development, Purospher STAR end-capped (250mm x 4.0mm), 5µm HPLC column, and gradient profile for mobile phase with constant 1.0 mL/min flow rate are used. Mobile phase A is a buffer of pH 8.5 containing 0.1% v/v of liquid ammonia in water with adjusted pH using 10% orthophosphoric acid, whereas mobile phase B is acetonitrile. The injection volume, column oven temperature, and autosampler temperature were 50 µL, 55 °C, and 5 °C, respectively. The data is acquired at 225 nm wavelength. The method yields a well-separated peak of 4-MBC from Venlafaxine and its impurities. This method is linear in the range of LOQ to 150% level of specification concentration of impurity and the observed correlation coefficient is 0.999. The repeatability and intermediate precision are evaluated and the respective values of %RSD for 4-MBC content are 0.43 and 0.93. Robustness studies show insignificant change for the system suitability criteria like %RSD, theoretical plates, and tailing factor, their values being well within the acceptance limit. The new method for the quantification of genotoxic impurity 4-MBC is precise, sensitive, rugged, and accurate; it also qualifies all the criteria of stability, linearity, and robustness.

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Section: Introductionmentioning

confidence: 99%

RP-HPLC Method for Content of Genotoxic 4-methoxybenzyl Chloride in Venlafaxine

Khadangale,

Dhalape,

Pinjari

2023

Orient. J. Chem

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A Review on Analytical Method for Determination of Venlafaxine HCl in Bulk and Pharmaceutical dosage form

Dighe

Siddheshwar

Shinde

2021

RJST

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Venlafaxine HCl is one of the antidepressant agent which comes under the category of serotonin-norepinephrine reuptake inhibitor i.e SNRI. This medication is usually used to treat major depressive disorder in adult. It may help to improve the mood and energy level and also to regain the interest in daily activities in the depressed person. The present review focus on various approaches for the analysis on Venlafaxine in bulk and pharmaceutical dosage forms. The review represents the various analytical method like the RP-HPLC, HPTLC, UV Spectroscopy and Stability Indicating Methods which were used for the investigation of Venlafaxine in bulk and different dosage formulations.

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New Simple Uv Spectrophotometric Method for Determination of Venlafaxine Hydrochloride in Pure and Pharmaceutical Formulation

Cited by 2 publications

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RP-HPLC Method for Content of Genotoxic 4-methoxybenzyl Chloride in Venlafaxine

RP-HPLC Method for Content of Genotoxic 4-methoxybenzyl Chloride in Venlafaxine

A Review on Analytical Method for Determination of Venlafaxine HCl in Bulk and Pharmaceutical dosage form

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