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开发并验证同时测定纯品和混合物中阿司匹林和泮托拉唑钠的色谱方法。

Development and Validation of Chromatographic Methods for Simultaneous Estimation of Aspirin and Pantoprazole Sodium in Pure and Mixture Form.

机构信息

Department of Quality Assurance and Pharmaceutical Chemistry, SSR College of Pharmacy, Sayli, Silvassa 396230, India.

Department of Pharmaceutical Sciences, Sardar Patel University, Vallabh Vidyanagar 388120, Anand, Gujarat, India.

出版信息

J Chromatogr Sci. 2024 May 31;62(5):477-482. doi: 10.1093/chromsci/bmae012.

Abstract

This technique is employed for the simultaneous quantification of aspirin (ASP) and pantoprazole sodium in both pure powder form and formulations. The high performance liquid chromatography (HPLC) method uses a C-18 column (250 mm × 4.6 mm, 5 μm) with a mobile phase consisting of 0.05 M disodium hydrogen phosphate and methanol in a 40:60% v/v ratio. The flow rate is maintained at 1.0 mL/min. On a layer of silica gel 60F254 with an aluminum backing, the high performance thin layer chromatography (HPTLC) separation was carried out with ethyl acetate and methanol (8: 1.5 v/v) as the mobile phase. With a mean recovery of 100.54% and 99.55% for ASP and PNT, respectively, quantification was accomplished using the HPLC method with UV detection at 286 nm over the concentration range of 0.1-0.6 g/mL for PNT and 0.4-2.4 g/mL for ASP. With a mean recovery of 99.44% and 99.01% for ASP and PNT, respectively, quantification was achieved using the HPTLC method with UV detection at 298 nm over the concentration range of 400-2400 ng/spot for ASP and 100-600 ng/spot for PNT, respectively. The methods can be used for the simultaneous determination of ASP and PNT in pure powder form and formulations as they are simple, accurate and sensitive.

摘要

该技术用于同时定量分析纯粉形式和制剂中的阿司匹林(ASP)和泮托拉唑钠。高效液相色谱(HPLC)法使用 C-18 柱(250mm×4.6mm,5μm),流动相由 0.05M 磷酸二氢钠和甲醇以 40:60%v/v 组成。流速保持在 1.0mL/min。在硅胶 60F254 薄层上,以乙酸乙酯和甲醇(8:1.5v/v)为流动相进行高效薄层色谱(HPTLC)分离。采用 HPLC 法,在 0.1-0.6g/mL 范围内对 PNT 进行 UV 检测,在 0.4-2.4g/mL 范围内对 ASP 进行 UV 检测,分别得到 ASP 和 PNT 的平均回收率为 100.54%和 99.55%。采用 HPTLC 法,在 298nm 处进行 UV 检测,在 400-2400ng/点范围内对 ASP 进行检测,在 100-600ng/点范围内对 PNT 进行检测,分别得到 ASP 和 PNT 的平均回收率为 99.44%和 99.01%。这些方法可用于同时测定纯粉形式和制剂中的 ASP 和 PNT,因为它们简单、准确和灵敏。

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