Green stability-indicating RP-HPTLC approach for determining suvorexant in commercial tablet dosage forms

IF 4.3 2区 化学 Q2 CHEMISTRY, MULTIDISCIPLINARY BMC Chemistry Pub Date : 2025-02-28 DOI:10.1186/s13065-025-01431-3
Prawez Alam, Faiyaz Shakeel, Mohammed H. Alqarni, Ahmed I. Foudah, Tariq M. Aljarba, Fatma M. Abdel Bar, Mohd Imran, Mohammad Ali
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Abstract

A novel sedative/hypnotic drug called suvorexant (SUV) is advised for treating insomnia. From a forensic standpoint, it is important medicine because of its sedative/hypnotic and depressing effects. There are no green “high-performance thin-layer chromatographic (HPTLC)” techniques for measuring SUV in the literature. Therefore, this study aims to develop and validate a reverse-phase HPTLC approach that indicates green stability for SUV measurement in commercially available tablet dosage forms. SUV was detected at 255 nm in wavelength. The suggested SUV analysis approach’s greenness was assessed using the “analytical eco-scale (AES), ChlorTox, and analytical GREEnness (AGREE)” tools. The current SUV analysis method showed linearity in the 10–1200 ng/band range. Furthermore, the SUV analytical method was robust, accurate (% recoveries = 98.18–99.30), sensitive (LOD = 3.32 ng/band and LOQ = 9.98 ng/band), precise (% CV = 0.78–0.94), and environmentally friendly. The “AES, total ChlorTox, and AGREE” scales were derived to be 93, 0.96 g, and 0.88, respectively, using the current SUV analytical method, demonstrating an exceptional greenness profile. SUV was shown to be suitably unstable under oxidative degradation conditions and suitably stable under acid, base, and heat degradation conditions. Furthermore, the SUV analytical method’s stability-indicating component identified SUV in the presence of its breakdown products. It was observed that marketed SUV tablet brands A and B contained, respectively, 98.18 and 101.32% of SUV. The findings of the study indicated that SUV in marketed tablet dosage forms may be monitored on a regular basis with the use of the current green HPTLC methodology.

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绿色稳定性指示RP-HPTLC法测定市售片剂剂型中补强剂
一种被称为suvorexant (SUV)的新型镇静/催眠药物被建议用于治疗失眠。从法医的角度来看,它是一种重要的药物,因为它具有镇静/催眠和抑制作用。在文献中没有绿色的“高性能薄层色谱(HPTLC)”技术来测量SUV。因此,本研究旨在开发并验证一种反相HPTLC方法,该方法表明了市售片剂剂型中SUV测量的绿色稳定性。SUV检测波长为255 nm。采用“分析生态尺度(AES)、ChlorTox和分析绿色度(AGREE)”工具对建议的SUV分析方法的绿色度进行了评估。目前的SUV分析方法在10-1200 ng/波段范围内呈线性。结果表明,该方法具有良好的鲁棒性、准确度(回收率为98.18 ~ 99.30)、灵敏度(LOD = 3.32 ng/band, LOQ = 9.98 ng/band)、精密度(% CV = 0.78 ~ 0.94)和环保性。使用当前的SUV分析方法,“AES,总氯tox和AGREE”尺度分别为93,0.96 g和0.88,显示出卓越的绿色概况。SUV在氧化降解条件下表现出适当的不稳定性,在酸、碱和热降解条件下表现出适当的稳定性。此外,SUV分析方法的稳定性指示组件在存在其击穿产物的情况下识别SUV。在市售SUV平板品牌A和B中,SUV的含量分别为98.18%和101.32%。研究结果表明,可以使用当前的绿色HPTLC方法定期监测市售片剂剂型中的SUV。
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来源期刊
BMC Chemistry
BMC Chemistry Chemistry-General Chemistry
CiteScore
5.30
自引率
2.20%
发文量
92
审稿时长
27 weeks
期刊介绍: BMC Chemistry, formerly known as Chemistry Central Journal, is now part of the BMC series journals family. Chemistry Central Journal has served the chemistry community as a trusted open access resource for more than 10 years – and we are delighted to announce the next step on its journey. In January 2019 the journal has been renamed BMC Chemistry and now strengthens the BMC series footprint in the physical sciences by publishing quality articles and by pushing the boundaries of open chemistry.
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