Abstract
[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.关键词
气相色谱/性能指标/验证评价/残留溶剂Key words
gas chromatography/performance indicators/verification and evaluation/residual solvents分类
医药卫生
