Stability-indicating high performance thin layer chromatography determination of Paroxetine hydrochloride in bulk drug and pharmaceutical formulations

Venkatachalam, A.; Chatterjee, Vidya S.

doi:10.1016/j.aca.2007.07.014

Cited by 17 publications

(10 citation statements)

References 7 publications

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“…Paroxetine can be extracted by solid phase extraction 29. Thin layer chromatography was used for determination of paroxetine in bulk drug and plasma 30. Stir bar sorptive extraction and liquid chromatography method was used for determination of paroxetine in plasma samples 31.…”

Section: Introductionmentioning

confidence: 99%

Construction and Performance Characterization of Ion‐Selective Electrodes for Potentiometric Determination of Paroxetine Hydrochloride in Pharmaceutical Preparations and Biological Fluids

2014

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Three types of ion‐selective electrodes: PVC membrane, modified carbon paste (CPE), and coated graphite electrodes (CGE) have been constructed for determining paroxetine hydrochloride (Prx). The electrodes are based on the ion pair of paroxetine with sodium tetraphenylborate (NaTPB) using dibutyl phthalate as plasticizing solvent. Fast, stable and potentiometric response was obtained over the concentration range of 1.1×10−5–1×10−2 mol L−1 with low detection limit of 6.9×10−6 mol L−1 and slope of a 56.7±0.3mV decade−1 for PVC membrane electrode, the concentration range of 2×10−5–1×10−2 mol L−1 with low detection limit of 1.2×10−5 mol L−1 and slope of a 57.7±0.6 mV decade−1 for CPE, and the concentration range of 2×10−5–1×10−2 mol L−1 with low detection limit of 8.9×10−6 mol L−1 and slope of a 56.1±0.1 mV decade−1 for CGE. The proposed electrodes display good selectivity for paroxetine with respect to a number of common inorganic and organic species. The electrodes were successfully applied to the potentiometric determination of paroxetine hydrochloride in its pure state, its pharmaceutical preparation, human urine and plasma.

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Section: Introductionmentioning

confidence: 99%

Construction and Performance Characterization of Ion‐Selective Electrodes for Potentiometric Determination of Paroxetine Hydrochloride in Pharmaceutical Preparations and Biological Fluids

2014

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“…To the best of our knowledge, HPTLC has not been previously reported for the stress testing of LAM and its determination in the presence of its forced degradation products. It is noteworthy that HPTLC has become an essential tool of modern analytical chemistry to assess the stability of a wide range of pharmaceuticals under a variety of stress conditions [12][13][14]. From another perspective, the International Conference on Harmonisation (ICH) guidelines Q1A [15] emphasize on the stability testing of new drug substances and products.…”

Section: Introductionmentioning

confidence: 99%

Stress Degradation Assessment of Lamotrigine Using a Validated Stability‐Indicating HPTLC Method

Michail

Daabees

Beltagy

et al. 2012

Journal of Chemistry

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In this work, a sensitive and stability-indicating HPTLC method for the determination of lamotrigine is presented. According to the International Conference on Harmonization guidelines Q1A, lamotrigine was exposed to a variety of stress conditions; these include heating in acidic, basic and neutral media. Its stability towards oxidative stress, humidity, high temperature and direct sunlight was also examined. Separation of the drug from its forced degradation impurities was achieved using TLC silica gel plates and a mobile phase composed of ethyl acetate: methanol: ammonia. The linear regression analysis of the data obtained for the correlation plots showed good linearity over the concentration range of 10–300 ng/spot. The forced degradation studies showed that lamotrigine is susceptible to degradation under acidic, basic, neutral and oxidative conditions, among which alkaline-induced hydrolysis had the highest degradative potential. Alternatively, the drug was stable under heat, humidity, and daylight stress factors. In order to assess the purity and stability of the drug in tablet formulations, the developed method was applied to the analysis of commercial tablets in brand and generic products. The obtained results showed that the degradation of the drug has not occurred in the marketed formulations that were analyzed by the described methodology.

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“…The methods reported for quantitative determination of PRX in tablets and/or biological fluids include voltammetry [5, 6], densitometry [7, 8], high-performance liquid chromatography [9–14], gas chromatography [15–17], and capillary electrophoresis [18]. These methods offered the required sensitivity and selectivity for the analysis of PRX in biological fluids; however, their sophisticated instrumentation and high analysis cost limited their routine use in quality control laboratories for analysis of PRX in its pharmaceutical tablets.…”

Section: Introductionmentioning

confidence: 99%

Simple Spectrophotometric Method for Determination of Paroxetine in Tablets Using 1,2‐Naphthoquinone‐4‐Sulphonate as a Chromogenic Reagent

Darwish

Abdine

Amer

et al. 2009

International Journal of Analytical Chemistry

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Simple and rapid spectrophotometric method has been developed and validated for the determination of paroxetine (PRX) in tablets. The proposed method was based on nucleophilic substitution reaction of PRX with 1,2-naphthoquinone-4-sulphonate (NQS) in an alkaline medium to form an orange-colored product of maximum absorption peak (λ max) at 488 nm. The stoichiometry and kinetics of the reaction were studied, and the reaction mechanism was postulated. Under the optimized reaction conditions, Beer's law correlating the absorbance (A) with PRX concentration (C) was obeyed in the range of 1–8 μg mL−1. The regression equation for the calibration data was: A = 0.0031 + 0.1609 C, with good correlation coefficients (0.9992). The molar absorptivity (ε) was 5.9 × 105 L mol−1 1 cm−1. The limits of detection and quantitation were 0.3 and 0.8 μg mL−1, respectively. The precision of the method was satisfactory; the values of relative standard deviations did not exceed 2%. The proposed method was successfully applied to the determination of PRX in its pharmaceutical tablets with good accuracy and precisions; the label claim percentage was 97.17 ± 1.06 %. The results obtained by the proposed method were comparable with those obtained by the official method.

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Stability-indicating high performance thin layer chromatography determination of Paroxetine hydrochloride in bulk drug and pharmaceutical formulations

Cited by 17 publications

References 7 publications

Construction and Performance Characterization of Ion‐Selective Electrodes for Potentiometric Determination of Paroxetine Hydrochloride in Pharmaceutical Preparations and Biological Fluids

Construction and Performance Characterization of Ion‐Selective Electrodes for Potentiometric Determination of Paroxetine Hydrochloride in Pharmaceutical Preparations and Biological Fluids

Stress Degradation Assessment of Lamotrigine Using a Validated Stability‐Indicating HPTLC Method

Simple Spectrophotometric Method for Determination of Paroxetine in Tablets Using 1,2‐Naphthoquinone‐4‐Sulphonate as a Chromogenic Reagent

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