Yomna A. Salem, Ahmed Emad F. Abbas, Amgad E. Salem, Aya A. Abdella, Amal A. El-Masry
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引用次数: 0
摘要
要应对快速发展的新型给药配方开发研究,拥有成熟的分析方法至关重要。在这项工作中,我们开发了一种高度绿色的快速色谱法,用于同时测定尼古丁(NIC)和咖啡因(CAF),并将其应用于新制备的快速雾化口腔喷雾剂(QMS)的体外释放研究,该口腔喷雾剂可在戒烟过程中起到快速缓解烟瘾的互补协同作用。色谱分析是在氰基色谱柱上进行的,使用等分泌(1.0 mL/ min)甘油:正磷酸(OPA)(0.2 M),用 0.05 M 三乙胺(5:95,v/v)调节 pH 值至 3.0,紫外检测波长为 260 nm。NIC和CAF在2.1和3.9 min (Rs = 5.64)时洗脱出清晰的峰,线性范围分别为0.1-20.0 µg/mL和0.2-40.0 µg/mL,检出限分别为0.03和0.07 µg/mL。所建立的方法具有良好的分析性能(准确度、精密度、稳健性和选择性),与应用GAPI、分析生态尺度、AGREE、BAGI和白度度量工具的已有方法相比,在实用性和生态学特征方面更胜一筹。所开发的方法成功地应用于药物制剂和人工唾液中 NIC 和 CAF 的测定,其结果与报道的方法无显著差异(F 检验和 t 检验)。此外,还采用所开发的方法对 QMS 中 NIC 和 CAF 的体外释放进行了研究,结果表明,与市场上销售的单组分制剂的混合扩散/聚合物链松弛相比,QMS 具有扩散控制释放的特点,这表明 QMS 在减少 NIC 和 CAF 的药物含量波动和提高其生物利用度方面具有优越性。
Multi-assessed green sustainable chromatographic resolution of nicotine and caffeine; application to in-vitro release from a new quick mist mouth spray co-formula
The availability of well-established analytical methods is crucial to cope with the fast-ongoing research for the development of new drug delivery formulations. In this work, a rapid highly green chromatographic method was developed for the simultaneous determination of nicotine (NIC) and caffeine (CAF) to be applied for an in-vitro release study from a newly prepared quick mist mouth spray co-formula (QMS), as a complementary synergistic fast-onset relief of cravings during smoking cessation. The chromatographic resolution was accomplished on a cyano column using isocratically delivered (1.0 mL/ min) glycerol: orthophosphoric acid (OPA) (0.2 M) adjusted to pH 3.0 using 0.05 M triethylamine (5:95, v/v) and UV detection at 260 nm. Well resolved peaks of NIC and CAF were eluted at 2.1 and 3.9 min (Rs = 5.64), with linear responses between 0.1 and 20.0 µg/mL and 0.2–40.0 µg/mL, and detection limits of 0.03 and 0.07 µg/mL for NIC and CAF, respectively. The developed method showed good analytical performance (accuracy, precision, robustness, and selectivity) as well as superiority in practicality and ecological profile compared to reported methods applying GAPI, analytical eco-scale, AGREE, BAGI, and whiteness metric tool. The developed method was successfully applied for NIC and CAF determination in their pharmaceutical preparations, and artificial saliva with no significant differences from reported method results (F-test and t-test). Moreover, an in-vitro release study of NIC and CAF from QMS was performed employing the developed method that revealed diffusion-controlled release, compared to mixed diffusion/ polymer chain relaxation for marketed single component formulation, showing the superiority of QMS in reducing drug level fluctuations of NIC and CAF and improving their bioavailability.
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.