稳定性指示超高效液相色谱- pda法测定缬更昔洛韦散装和片剂的含量

S. Mondal, Goluguri Sunil Reddy, P. Mondal, V. Prathyusha, Aishwarya P Nair, S. Rahaman
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引用次数: 5

摘要

背景:本文系统建立了超高效液相色谱(UPLC)定量测定缬更昔洛韦原料药和剂型药的方法。随后进行了验证和降解研究。方法:采用HSS (100x2.1 mm, 1.8m)进行色谱分离。用含有0.01N正磷酸二氢钾和乙腈(55:45 v/v)的混合物的等压流动相。流动相流速为0.3 ml/min,柱温为30℃,检测波长为254 nm。根据ICH指南对所开发的方法进行了线性、准确度、精密度、特异性、检出限和鲁棒性的验证。结果:结果精密度(RSD %)小于1.0%。该方法的准确度分别为50%、100%和150%。在25 ~ 150 μg/ml范围内,曲线呈线性,相关系数为0.9997。伐更昔洛韦的回收率在98 ~ 102%范围内,检出限分别为0.933和2.827 μg/ml。在酸性、碱性、氧化、光解和热条件下进行了强制降解研究,以证明所开发的UPLC方法具有稳定性指示能力。结论:该方法符合ICH指南,可用于缬更昔洛韦片剂的含量测定。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
A New Stability Indicating Ultra Performance Liquid Chromatography-PDA Method for the Estimation of Valganciclovir in Bulk and Tablet Dosage Form
Background: The present article described about the systemic development of ultra-performance liquid chromatography (UPLC) method for the quantitative determination of valganciclovir in bulk and dosage form. The subsequent validation and degradation study was also performed. Methods: The chromatographic Separation was achieved with an HSS (100x2.1 mm, 1.8m).column with an isocratic mobile phase containing a mixture of 0.01N potassium dihydrogen orthophosphate and acetonitrile (55:45 v/v). The flow rate of the mobile phase was 0.3 ml/min with a column temperature of 30°C and detection wavelength at 254 nm. The developed method was validated according to the ICH guidelines with respect to linearity, accuracy, precision, specificity, detection limits and robustness. Results: The precision of the results, stated as the %RSD was below 1.0%. The accuracy of the method demonstrated at three levels in the range of 50%, 100% and 150% of the specification limit. The calibration curve was linear over a concentration range from 25 to 150 μg/ml with a correlation coefficient of 0.9997. The recovery of valganciclovir was found to be in the range of 98 to 102%, whereas the detection limits were found to be 0.933 and 2.827 μg/ml. Forced degradation study was carried out under acidic, alkaline, oxidative, photolytic and thermal conditions to prove the stability-indicating ability of the developed UPLC method. Conclusion: The method is validated according to the ICH guidelines and it is applied successfully for the determination of valganciclovir in tablets.
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