实验技术与管理

通过对标进口气相色谱仪，该研究对两家国产气相色谱仪进行了性能指标验证和溶剂残留方法学的应用验证。结果表明国产仪器各项性能指标均能满足要求：基线噪声小于0.05 p A、基线漂移小于0.2 pA、检测限小于5×10^–12 g/s、定性和定量重复性分别小于0.2%和1.0%。在此基础上完成了消旋卡多曲化学品中11种残留溶剂的方法学验证对比，结果表明该方法线性关系良好(相关系数r≥0.999)、回收率为95.57%～99.84%、相对标准偏差(RSD)小于3.6%(n=9)。国产气相色谱仪的灵敏度、精密度和准确度等性能与进口设备差异不大，能满足企事业单位的检测要求，高效响应客户需求优于进口设备，但国产仪器工作站的部分参数项需进一步优化。

[Objective] To facilitate the development and application of mid-to-high-end domestic scientific instruments, this study establishes a comprehensive “Domestic Scientific Instrument Verification and Evaluation System” by rigorously assessing the performance validation and practical application. Focusing on gas chromatography technology, comparative evaluations between two domestic gas chromatographs(GCs) and their imported counterparts were conducted. The evaluations encompassed both fundamental performance metrics and methodological validation for residual solvent analysis. This systematic approach promotes technological optimization and accelerates the adoption of domestic analytical instruments in professional laboratories. [Methods] This study systematically evaluated the performance and practical applications of two domestic GCs(FID detectors) compared with their imported counterparts. Performance verification included the testing of carrier gas flow rate, inlet pressure, baseline drift and noise, detection limits, qualitative and quantitative repeatability, and injection carryover. Because current standards lack specifications for the assessment of carrier gas flow rate, this study innovatively implements dual measurement approaches using soap-film and electronic flowmeters. A comparative evaluation revealed that these two domestic GCs exhibited performance metrics comparable to those of their imported counterparts, with all the systems complying with the requirements of national standards(GB/T 30431—2020). In the subsequent practical application validation, Racecadotril, a compound listed in the Chinese Pharmacopoeia(2020 edition), was selected to establish and validate an analytical method for detecting 11 organic solvent residues. The validation covered the parameters of specificity, linearity and range, detection limits, quantitation limits, accuracy, precision, and robustness. The solvent panel comprised 11 compounds, including 3 complex low-concentration analytes(tetrahydrofuran, n-hexane, and isopropyl ether, with concentrations of 0.02%～0.072%). Hence, the panel encompassed the entire concentration range from trace-level to upper-limit specifications and ensured the representativeness of the method. This approach comprehensively assessed the key performance characteristics of domestic instruments, including sensitivity, accuracy, methodological validity, and operational feasibility. Therefore, the evaluation provided definitive evidence of the instruments' compliance with stringent standards for analytical methods. [Results] Both domestic GCs satisfied all performance requirements. Their performance was comparable to that of the imported counterparts, i.e., they demonstrated the following parameters: baseline noise <0.05 pA, baseline drift <0.2 pA, detection limit <5×10^-12 g/s, qualitative and quantitative repeatability <0.2% and 1.0%, respectively, with excellent flow rate accuracy and stability, and injection carryover <0.1%. Comprehensive method validation for the 11 residual solvents in Racecadotril demonstrated excellent performance characteristics, with the following observed values: linear regression correlation(r≥0.999, n=6 calibration points), mean recovery of 95.57%–99.84% across three spike levels, intermediate precision(RSD<3.6%, n=9), and LOQ precision(RSD<7.0%). This optimized protocol provided simple, accurate, and precise simultaneous quantification, with domestic GCs exhibiting superior performance in detecting low-abundance solvents compared to the imported counterparts. [Conclusions] Modern domestic GCs comply with all applicable national standards(GB/T 30431—2020) and offer distinct competitive advantages, including superior technical support responsiveness and operator-centric interfaces featuring Mandarin-optimized workflow designs. Although the workstation software for these instruments requires further optimization for advanced data processing(particularly concerning multivariate analysis and custom reporting functions), the fundamental analytical capabilities of the instruments demonstrate parity with those of the imported counterparts. These findings provide a robust foundation for ongoing quality assessment and support the strategic adoption of domestic instruments. Future studies need to focus on evaluations for long-term reliability to complete the verification paradigm and facilitate the transition to domestic analytical instrumentation in professional laboratories.