Stability Indicating Methods for Determination of Donepezil Hydrochloride According to ICH Guidelines

Abbas, Samah S.; Fayez, Yasmin M.; Fattah, Laila El-Sayed Abdel

doi:10.1248/cpb.54.1447

Cited by 11 publications

(4 citation statements)

References 7 publications

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“…Based on the investigation of forced degradation behavior in our work, donepezil was found to be stable under mild acidic condition and alkaline condition, but sensitive to degradation with hydrogen per- oxide, which is also reported in earlier studies on stability of donepezil hydrochloride [17][18][19][20][21]. Even if it appears stable under mild conditions, in our experiment degradation was achieved in alkaline solution under more severe conditions, using high molarity alkaline solution and reflux.…”

Section: Resultssupporting

confidence: 82%

Liquid chromatography and liquid chromatography-mass spectrometry analysis of donepezil degradation products

Mladenović¹,

Jadranin

Pavlović³

et al. 2015

CI&CEQ

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This study describes the investigation of degradation products of donepezil (DP) using stability indicating RP-HPLC method for determination of donepezil, which is a centrally acting reversible acetylcholinesterase inhibitor. In order to investigate the stability of drug and formed degradation products, a forced degradation study of drug sample and finished product under different forced degradation conditions has been conducted. Donepezil hydrochloride and donepezil tablets were subjected to stress degradation conditions recommended by International Conference on Harmonization (ICH). Donepezil hydrochloride solutions were subjected to acid and alkali hydrolysis, chemical oxidation and thermal degradation. Significant degradation was observed under alkali hydrolysis and oxidative degradation conditions. Additional degradation products were observed under the conditions of oxidative degradation. The degradation products observed during forced degradation studies were monitored using the high performance liquid chromatography (HPLC) method developed. The parent method was modified in order to obtain LC-MS compatible method which was used to identify the degradation products from forced degradation samples using high resolution mass spectrometry. The mass spectrum provided the precise mass from which derived molecular formula of drug substance and degradation products formed and proved the specificity of the method unambiguously. [Projekat Ministarstva nauke Republike Srbije, br. 172013]

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Section: Resultssupporting

confidence: 82%

Liquid chromatography and liquid chromatography-mass spectrometry analysis of donepezil degradation products

Mladenović¹,

Jadranin

Pavlović³

et al. 2015

CI&CEQ

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“…The estimation of the limit of detection or quantitation was done on the basis of the ICH guidelines (Abbas, Fayez, & Abdel, 2006). The LOD (limit of detection, S/N ≥ 3) and the LOQ (limit of quantification, S/N ≥ 10) were measured according to the response and the slope.…”

Section: Ta B L Ementioning

confidence: 99%

Purification, characterization, and identification of 3‐hydroxy‐4‐methoxy benzal acrolein–an intermediate of synthesizing advantame

Chen

Qiang

Wang

et al. 2020

Food Science & Nutrition

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Advantame is a novel sweetener, and 3‐hydroxy‐4‐methoxy benzal acrolein is an important intermediate to synthesize the sweetener. The aim of this study was to evaluate a new low‐cost method to purify 3‐hydroxy‐4‐methoxy benzal acrolein, and the crude intermediate was used as raw material. The intermediate was purified using a low‐pressure column chromatography with a C18 column, using a methanol‐water (6:4, v/v) at a flow rate of 6.0 ml/min, and the loading amount of the crude intermediate in solution was 10.0 mg in total. A method for the analysis of 3‐hydroxy‐4‐methoxy benzal acrolein was established using high‐performance liquid chromatography (HPLC). This method was validated in terms of its linearity, repeatability, accuracy, detection limit, and quantitation limit. The calibration curves of 3‐hydroxy‐4‐methoxy benzal acrolein were linear (r > .999) over a wide concentration range of 0.005–0.08 mg/ml, by comparing the ratio of signal to noise, and the detection limit was 5.0 ng/ml and the quantification limit was 15.0 ng/ml. Good repeatability was obtained (RSD < 2%, n = 6), and the recoveries calculated using mixed sample previously quantified ranged from 94.5% to 106.37%. As long as, this method has been successfully applied to the analysis of 3‐hydroxy‐4‐methoxy benzal acrolein; therefore, the method can be put into practical use during the industrial synthesis and real‐time detection of the intermediate.

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“…Various strategies, such as HPLC‐UV [19], HPLC‐fluorescence [20] and HPLC‐MS detection [21], have been conducted for quantifying DPZ. Also, stability‐revealing techniques have been published [22].…”

Section: Introductionmentioning

confidence: 99%

A green micelle‐enhanced first derivative synchronous fluorescence approach for determination of donepezil HCl and trazodone HCl in their pure state, pharmaceutical dosage form and spiked human plasma

Abd El wahab,

Saad,

Sheribah

et al. 2024

Luminescence

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The study's objective is to establish an eco‐friendly, sensitive and economical quantitative methodology for the concurrent analysis of donepezil HCl (DPZ) and trazodone HCl (TRZ) in raw materials, tablets and human plasma. The first derivative synchronous fluorescence spectroscopic (FDSFS) technique was applied at constant wavelength difference (∆λ = 120) for assessment of DPZ and TRZ at each other's zero‐crossing point at 279 nm and 297 nm, respectively. The submitted technique was validated in accordance with ICH Q2 R1 guidelines and the linearity of the standard calibration curve was observed over the concentration range of 10–500 ng/ml for DPZ and 20–1,000 ng/ml for TRZ. The detection limits (LOD) were found to be 2.65 and 5.4 ng/ml, and the limits of quantitation (LOQ) were 8.05 and 16.3 ng/ml for DPZ and TRZ, respectively. This technique was used further to quantify the studied medications in their laboratory‐prepared mixtures, commercial tablets and spiked plasma samples. The results obtained were not significantly different from those acquired from the comparison methods, indicating the high accuracy and precision of the proposed method. Furthermore, the ecological friendliness of the suggested method was evaluated and proven to be excellent using Green Analytical Procedure Index (GAPI) and Analytical GREEnness (AGREE) evaluation tools.

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Stability Indicating Methods for Determination of Donepezil Hydrochloride According to ICH Guidelines

Cited by 11 publications

References 7 publications

Liquid chromatography and liquid chromatography-mass spectrometry analysis of donepezil degradation products

Liquid chromatography and liquid chromatography-mass spectrometry analysis of donepezil degradation products

Purification, characterization, and identification of 3‐hydroxy‐4‐methoxy benzal acrolein–an intermediate of synthesizing advantame

A green micelle‐enhanced first derivative synchronous fluorescence approach for determination of donepezil HCl and trazodone HCl in their pure state, pharmaceutical dosage form and spiked human plasma

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