DoE-enhanced development and validation of eco-friendly RP-HPLC method for analysis of safinamide and its precursor impurity: QbD approach

El‐Sayed, Heba M.; Abdellatef, Hisham E.; Hendawy, Hassan A.M.; El-Abassy, Omar M.; Ibrahim, Hany

doi:10.1016/j.microc.2023.108730

Cited by 14 publications

(8 citation statements)

References 45 publications

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“…The Green Certificate-modified Eco-Scale evaluates analytical procedure characteristics such as reagent toxicity, instrumental energy consumption, and toxic compound emissions to the environment, as well as reagent and solvent volumes used and waste generation, which are scored using a penalty-point system 42 . As shown in Table 4 , the proposed method is greener than the reported HPLC–UV method 26 .…”

Section: Methods Validationmentioning

confidence: 90%

“…A thorough review of the literature has identified a number of analytical approaches, such as HPLC 21 – 26 , HPTLC 27 , UPLC 28 , electrochemical 29 , 30 , and UV-spectrophotometric methods 31 that can accurately quantify SAF alone or in combination with other drugs. To our knowledge, there is currently no eco-friendly spectrofluorimetric method for determining SAF in the presence of its related impurity.…”

Section: Introductionmentioning

confidence: 99%

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Ecofriendly micellar mediated spectrofluorimetric method for ultrasensitive quantification of the antiparkinsonian drug safinamide in pharmaceutical formulation and spiked human plasma

Ibrahim,

Marzouk,

Hegazy

et al. 2024

Sci Rep

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A novel, highly sensitive and eco-friendly micellar-mediated spectrofluorimetric method was developed and validated for the determination of the novel antiparkinsonian drug safinamide mesylate in the presence of its related precursor impurity, 4-hydroxybenzaldehyde. The proposed approach relies on increasing the inherent fluorescence emission at 296 nm of safinamide, by forming hydrogen bonds between the mentioned drug and sodium dodecyl sulfate in the micellar system using 0.1 N HCl as a solvent, following excitation at 226 nm. A thorough investigation was conducted into the experimental factors affecting spectrofluorimetric behavior of the studied drug. A linearity plot of safinamide over the concentration range of 10.0–1000.0 ng/mL against the relative fluorescence intensities was established. The proposed method demonstrated excellent sensitivity down to the nano-gram level with detection and quantitation limits of 1.91 and 5.79 ng/mL, respectively. The studied drug was effectively determined in Parkimedine® Tablets. Furthermore, the proposed method allows for ultrasensitive quantification of safinamide in spiked human plasma, with satisfactory percentage recovery (98.97–102.28%). Additionally, the greenness assessment using the advanced green certificate classification approach, the complementary green analytical procedure index (Complex-GAPI), and the analytical GREEness metric approach (AGREE), along with the practicality check using the Blue Applicability Grade Index in addition to the all-inclusive overall whiteness evaluation using the RGB-12 model were carried out. The outcomes demonstrated the effectiveness and whiteness of the proposed technique. Clearly, the suggested approach has the advantages of being simple, requiring no pretreatment steps, and relying solely on direct measuring procedures.

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Section: Methods Validationmentioning

confidence: 90%

Section: Introductionmentioning

confidence: 99%

Ecofriendly micellar mediated spectrofluorimetric method for ultrasensitive quantification of the antiparkinsonian drug safinamide in pharmaceutical formulation and spiked human plasma

Ibrahim,

Marzouk,

Hegazy

et al. 2024

Sci Rep

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“…A total of 0.02 g of the pure drug was dissolved in a mobile phase of acetonitrile and acidified water (0.7 mL of H 3 PO 4 in 1000 mL of water at 50/50%) in a 25 mL volumetric flask. Further dilutions were then performed to obtain 10, 20, 30, 40, and 50 µg/mL drug with the mobile phase as the solvent 45 .…”

Section: Preparation Of Stock Solutionsmentioning

confidence: 99%

“…All assays were conducted at room temperature and under 220 nm detection conditions. The auto sample was programmed to 20 µl injections 45 .…”

Section: Analysis Conditionsmentioning

confidence: 99%

تقنية كرموتوغرافيا السائل ذات الاداء العالي ذوالطور العكسي مع كاشف الاشعة الفوق البنفسجية لتقدير ادوية الايبو بروفين والتنوكسيكام في الصورة النقية و الاقراص الدوائية

Mhdi,

Abed

2024

Baghdad Sci.J

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استخدمت تقنية الكروماتوغرافيا السائل ذات الأداء العالي ذات الطور العكسي مع كاشف الأشعة فوق البنفسجية حساس بدرجة كافية لقياس الكمية الضئيلة للدواء التنوكسيكام والايبو بروفين . في الدراسة الحالية ، تمت المعايرة بطريقة بسيطة وسريعة لتقدير الدوائين في عينات نقية وصيدلانية. تم فصل المواد التحليلية على عمود من الطور الساكن كاربون 18 ( 150 ملمتر في 4،6 ملمتر وقطر 5 مايكروميتر) . يشمل الطور المتحرك على الاسيتو نايتريل و الماء المحمض ( 0.7 مل من حامض الفسفوريك في 1000 مل من الماء ) وسرعة تدفق 1 مل بالدقيقة وحقن نموذج 20 مايكروليتر في درجة حرارة الغرفة .نتائج الفصل اجريت على المادة النقية اولا ثم على الاقراص الدوائية لكلا الدوائين ثم عمل منحني معايرة لكل مادة نقية باخذ 5 تراكيز . وتم التاكد من تميز الطريقة وخطية العلاقة من حيث الدقة والضبط جيدة وحد الكشف كان 1.5677 جزء جزء من المليون للتنوكسيكام و 0.7911 جزء جزء من المليون لللايبوبروفين للتركيزالمعين لكل دواء ونتائج هذه الطريقة كانت ملائمة لتقدير كلا الدوائين في كميات ضئيلة وبالصورة النقية والدوائية.

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“…The environmentally friendly analytical chemistry procedure involves analyzing the smallest possible samples with the smallest sample size possible [19,20] QbD and Green Chemistry can help develop analytical methods that are more e cient, effective, and environmentally friendly. By considering the impact of critical factors on the quality of the method and the environment, QbD and Green Chemistry can ensure that analytical methods are developed with the right quality attributes, while minimizing the use of hazardous substances and waste [21][22][23]. The utilization of 12 principles to assess the environmental friendliness of an analysis technique, employing resources like the National Environmental Methods Index (NEMI) is being revamped through the development of a novel tool known as GAPI (Green Analytical Procedure Index) [24].…”

Section: Introductionmentioning

confidence: 99%

Advancing Quality and Environmental Responsibility: A Stability-Indicating LC Method Development for Lenvatinib Through QbD and Green Chemistry

Tiwari

Patel

2023

Chromatographia

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A Quality by Design (QbD) technique that was systematic and analytical was utilized to create and con rm a novel and sensitive stability-indicating method of Lenvatinib via the HPLC method. To comply with ICH Q1(A) guidelines, a study was conducted to determine the degradation behavior of Lenvatinib under various environmental conditions. The QbD approach involved screening and optimization, which included using Placket Burman to assess primary parameters, and Response Surface Design (RSD) to optimize critical factors. The degradation was examined under different degradation conditions, including acidic, basic, oxidative, neutral, thermal, and photolytic, and was separated using a Shimadzu® C18 column (250 mm x 4.6 mm, particle size 5 µ). The mobile phase consisted of a concentration of Acetonitrile: 10 mM ammonium acetate having pH 3.5 (39:61, v/v) at a ow rate of 0.8 mL/min, 20 min run time, and 245 nm wavelength. The drug was particularly sensitive towards acidic and basic hydrolysis stress conditions, which generated a total of ve degradant products that were successfully identi ed with the optimized LC-MS compatible analytical method. The optimized method was found to be sensitive, reproducible, speci c, and robust, with a linearity range of 10 to 60 mg/mL and a correlation coe cient (R 2 = 0.9993). The greenness score of the analytical method was calculated, and it was observed that the developed method was environmentally friendly.

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DoE-enhanced development and validation of eco-friendly RP-HPLC method for analysis of safinamide and its precursor impurity: QbD approach

Cited by 14 publications

References 45 publications

Ecofriendly micellar mediated spectrofluorimetric method for ultrasensitive quantification of the antiparkinsonian drug safinamide in pharmaceutical formulation and spiked human plasma

Ecofriendly micellar mediated spectrofluorimetric method for ultrasensitive quantification of the antiparkinsonian drug safinamide in pharmaceutical formulation and spiked human plasma

Advancing Quality and Environmental Responsibility: A Stability-Indicating LC Method Development for Lenvatinib Through QbD and Green Chemistry

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