Applying green analytical chemistry (GAC) for development of stability indicating HPLC method for determining clonazepam and its related substances in pharmaceutical formulations and calculating uncertainty

Eldin, Ahmed Badr; Shalaby, A.; Abdallah, Mahmoud S.; Shaldam, Moataz A.; Abdallah, Mohamed Adel

doi:10.1016/j.arabjc.2014.10.051

Cited by 18 publications

(10 citation statements)

References 8 publications

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“…Liquid chromatography has been frequently used in food and medicine fields, and many HPLC methods have been developed for analysing target constituents such as isoflavonoids, sweeteners, caffeine, alkaloids, statins and clonazepam using some benign mobile phase additives (e.g. ethanol, cyclodextrins and deep eutectic solvents); however, acetonitrile and methanol were used in most of these analytical processes (Sik, 2012;Zeng et al, 2012aZeng et al, , 2012bEldin et al, 2014;Assassi et al, 2015;Tan et al, 2016). Acetonitrile, methanol, trifluoroacetic acid and high concentration of formic acid solutions were frequently used as HPLC mobile phases to analyse anthocyanins from various sources (Welch et al, 2008;Barnes et al, 2009;Zheng et al, 2011;Su et al, 2016).…”

Section: Introductionmentioning

confidence: 99%

Development of a green two‐dimensional HPLC‐DAD/ESI‐MS method for the determination of anthocyanins from Prunus cerasifera var. atropurpurea leaf and improvement of their stability in energy drinks

Chen

Sang

Zhang

et al. 2018

Int J of Food Sci Tech

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Summary This study aimed to develop a green two‐dimensional HPLC‐DAD/ESI‐MS method for analysing anthocyanins from Prunus cerasifera var. atropurpurea leaf and improve their stability in energy drinks by the addition of phenolic acids. Ethanol and tartaric acid solutions were used as mobile phases for one‐dimensional HPLC‐DAD for quantitative analysis of anthocyanins, and the primary anthocyanins were identified as cyanidin‐3‐O‐galactoside, cyanidin‐3‐O‐glucoside and cyanidin‐3‐O‐rutinoside using two‐dimensional HPLC‐MS. Method validation showed that the developed method was accurate, stable and reliable for the analysis of P. cerasifera anthocyanins. The effects of gallic, ferulic and caffeic acid on the stability of cyanidin‐3‐O‐galactoside, cyanidin‐3‐O‐glucoside, cyanidin‐3‐O‐rutinoside and total anthocyanins from P. cerasifera leaf in energy drinks were evaluated, and the degradation of P. cerasifera anthocyanins ideally followed a first‐order model (R2 > 0.98). Gallic acid showed stronger protective effects on P. cerasifera anthocyanins in energy drinks, and adding/increasing ferulic and caffeic acids accelerated the degradation reactions.

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Section: Introductionmentioning

confidence: 99%

Development of a green two‐dimensional HPLC‐DAD/ESI‐MS method for the determination of anthocyanins from Prunus cerasifera var. atropurpurea leaf and improvement of their stability in energy drinks

Chen

Sang

Zhang

et al. 2018

Int J of Food Sci Tech

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“…The development and evolution of the scientific literature related to the assessment of green analytical methods is growing annually, due to the need to advance new practices that comply with ecological requirements [ 61 , 62 , 63 , 64 , 65 , 66 , 67 , 68 ]. The emergence of many greenness assessment studies has gained attention as they are intended to reduce waste production, energy consumption, and cost and generate eco-friendly methods.…”

Section: Resultsmentioning

confidence: 99%

Application of Three Ecological Assessment Tools in Examining Chromatographic Methods for the Green Analysis of a Mixture of Dopamine, Serotonin, Glutamate and GABA: A Comparative Study

et al. 2021

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The assessment of greenness of analytical protocols is of great importance now to preserve the environment. Some studies have analyzed either only the neurotransmitters, dopamine, serotonin, glutamate, and gamma-aminobutyric acid (GABA), together or with other neurotransmitters and biomarkers. However, these methods have not been investigated for their greenness and were not compared with each other to find the optimum one. Therefore, this study aims to compare seven published chromatographic methods that analyzed the four neurotransmitters and their mixtures using the National Environmental Method Index, Analytical Eco-Scale Assessment (ESA), and Green Analytical Procedure Index (GAPI). As these methods cover both qualitative and quantitative aspects, they offer better transparency. Overall, GAPI showed maximum greenness throughout the analysis. Method 6 was proven to be the method of choice for analyzing the mixture, owing to its greenness, according to NEMI, ESA, and GAPI. Additionally, method 6 has a wide scope of application (13 components can be analyzed), high sensitivity (low LOQ values), and fast analysis (low retention times, especially for glutamate and GABA).

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“…The large peak in Figure 12C was an oxidative degradation peak of CZP [37]. This degradation peak might be a related pharmaceutical impurity of CZP, which is known as CZP related compound A (3-amino-4-2-(chlorohprnyl)-6-nitrocarbostyril) [37,38]. The proposed RP-HPLC method was able to detect EST and CZP simultaneously in the presence of their degradation products, indicating the stability-indicating property.…”

Section: Forced Degradation Studiesmentioning

confidence: 94%

“…Hence, the CZP was also sufficiently stable under all degradation conditions. The large peak in Figure 12C was an oxidative degradation peak of CZP [37]. This degradation peak might be a related pharmaceutical impurity of CZP, which is known as CZP related compound A (3-amino-4-2-(chlorohprnyl)-6-nitrocarbostyril) [37,38].…”

Section: Forced Degradation Studiesmentioning

confidence: 99%

Simultaneous Estimation of Escitalopram and Clonazepam in Tablet Dosage Forms Using HPLC-DAD Method and Optimization of Chromatographic Conditions by Box-Behnken Design

et al. 2022

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The study aimed to develop a new reverse-phase high-performance liquid chromatography (RP-HPLC) method with diode array detection (DAD) detection for simultaneous estimation of escitalopram (EST) and clonazepam (CZP) in tablet dosage forms with a quality by design (QbD) approach. The chromatographic conditions were optimized by Box-Behnken design (BBD) and developed method was validated for the linearity, system suitability, accuracy, precision, robustness, sensitivity, and solution stability according to International Council for Harmonization (ICH) guidelines. EST and CZP standard drugs peaks were separated at retention times of 2.668 and 5.046 min by C-18 column with dimension of 4.6 × 100 mm length and particle size packing 2.5 µm. The mobile phase was methanol: 0.1% orthophosphoric acid (OPA) (25:75, v/v), with a flow rate of 0.7 mL/min at temperature of 26 °C. The sample volume injected was 20 µL and peaks were detected at 239 nm. Using the standard calibration curve, the % assay of marketed tablet was founded 98.89 and 98.76 for EST and CZP, respectively. The proposed RP-HPLC method was able to detect EST and CZP in the presence of their degradation products, indicating the stability-indicating property of the developed RP-HPLC method. The validation parameter’s results in terms of linearity, system suitability, accuracy, precision, robustness, sensitivity, and solution stability were in an acceptable range as per the ICH guidelines. The newly developed RP-HPLC method with QbD application is simple, accurate, time-saving, and economic.

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Applying green analytical chemistry (GAC) for development of stability indicating HPLC method for determining clonazepam and its related substances in pharmaceutical formulations and calculating uncertainty

Cited by 18 publications

References 8 publications

Development of a green two‐dimensional HPLC‐DAD/ESI‐MS method for the determination of anthocyanins from Prunus cerasifera var. atropurpurea leaf and improvement of their stability in energy drinks

Development of a green two‐dimensional HPLC‐DAD/ESI‐MS method for the determination of anthocyanins from Prunus cerasifera var. atropurpurea leaf and improvement of their stability in energy drinks

Application of Three Ecological Assessment Tools in Examining Chromatographic Methods for the Green Analysis of a Mixture of Dopamine, Serotonin, Glutamate and GABA: A Comparative Study

Simultaneous Estimation of Escitalopram and Clonazepam in Tablet Dosage Forms Using HPLC-DAD Method and Optimization of Chromatographic Conditions by Box-Behnken Design

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