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Method Development and Force Degradation Study for Daclatasvir Using LC-MS/MS

机译：LC-MS / MS法开发达克拉斯韦的方法和降解力的研究

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Daclatasvir (DCV) used for the treatment of chronic hepatitis C virus infection (HCV). The present piece of work contains development, validation and force degradation study for DCV has been carried out by using LC-MS/MS technique. The LC-MS system contains 4000 QTrap along with the Shimadzu LC 20AD LC System, controlled by Analyst 1.4.2 software for present study. For the preparation of standard drug DCV and its marketed formulations the diluent used was acetonitrile: water (50:50v/v). LC system runs with the conditions like use of C18 column (Thermo Scientific, 5µm, 4.6 X 250 mm size), column temperature 25°C (Ambient), Injection volume 2 µL, total run time 10 min, flow rate 0.5 mL/min and an isocratic mobile phase consist of 1mM Ammonium acetate Buffer pH=4 adjusted with 50% acetic acid in water as ‘A’ and acetonitrile as a solvent ‘B’ (20:80 v/v). Validation was carried out by testing parameters like LOD (limit of detection), LOQ (Limit of quantification) linearity, ruggedness, accuracy and precision in terms of reproducibility, repeatability according to ICH guidelines. The calibration range for DCV was 500 to 5000 ng/mL, where 800, 1600 & 3200 ng/mL concentrations of DCV set as an Internal QC with proper labeling. All Three QC samples applied n=6 times. For Mass spectrometry (MS) quantification of the DCV, the interest of mass m/z 740.50/514.10 was considered. The force degradation study has been carried out on LC-MS for DCV at different stress conditions. The drug was found to be stable in acidic, neutral, oxidative and photolytic but degrades in basic conditions. The proposed method is fast, economical, avoiding chemical steps and wet chemistry and thus provides a comparatively simpler, rapid green method for routine analysis in pharmaceutical industries.
机译：达克他韦（DCV）用于治疗慢性丙型肝炎病毒感染（HCV）。目前的工作包括使用LC-MS / MS技术对DCV进行开发，验证和力退化研究。 LC-MS系统包含4000 QTrap以及Shimadzu LC 20AD LC系统，由本研究的Analyst 1.4.2软件控制。为了制备标准药物DCV及其市售制剂，使用的稀释剂为乙腈：水（50：50v / v）。液相色谱系统在以下条件下运行：使用C18色谱柱（Thermo Scientific，5µm，4.6 X 250 mm尺寸），色谱柱温度25°C（环境），进样量2 µL，总运行时间10分钟，流速0.5 mL / min等度流动相由1mM乙酸铵缓冲液pH = 4组成，用50％的乙酸水溶液在水中调节为'A'，在乙腈中调节溶剂为'B'（20:80 v / v）。根据ICH指南，通过测试参数（如LOD（检测限），LOQ（定量限）线性，坚固性，准确性和精密度）来进行验证。 DCV的校准范围为500至5000 ng / mL，其中800、1600和3200 ng / mL浓度的DCV设置为内部QC，并带有适当的标签。所有三个QC样品均施加n = 6次。对于DCV的质谱（MS）定量，考虑了质量m / z 740.50 / 514.10的重要性。力退化研究已经在不同应力条件下针对DCV的LC-MS上进行了研究。发现该药物在酸性，中性，氧化性和光解性方面稳定，但在碱性条件下会降解。所提出的方法快速，经济，避免了化学步骤和湿化学反应，因此为制药行业的常规分析提供了一种相对简单，快速的绿色方法。

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