奈吡坦和帕洛诺司琼原料药和制剂的光稳定性指示高效液相色谱验证技术

P. Salomi, B. Sireesha, Afreen Sultana, R. Reddy
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引用次数: 1

摘要

分析化学是一门寻求不断改进测量天然和人造材料化学成分的方法的科学。Netupitant延迟呕吐在很大程度上与速激肽家族神经激肽1受体的激活有关。帕洛诺司琼是一种选择性5-羟色胺5-HT3受体拮抗剂。该药物的止吐活性是通过抑制中枢和外周存在的5-HT3受体来实现的,从而抑制呕吐中枢的内脏传入刺激。流动相为正磷酸盐和乙酸酯,pH = 70%缓冲液,甲醇= 30%。采用片剂对尼图匹坦和帕拉诺司琼的含量进行测定,其%含量分别为100.08和100.04,线性关系良好,相关系数分别为0.999,精密度分别为0.8和0.3,表明方法精密度高。方法的验证结果表明,该方法的准确度完全在限定范围内,具有良好的准确度和重复性。Netupitant的LOD和LOQ分别为3.02和9.98,Palanosetron的LOD和LOQ分别为3.00和10.00。结果表明,该方法指示稳定、灵敏、准确、鲁棒性强、精度高。因此,所建立的高效液相色谱法可以成功地应用于药物剂型的分析,并可用于常规分析。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
A Photo Stability Indicating HPLC technique for Validation of Netupitant and Palonosetron in Bulk and Formulations
Analytical chemistry is the science that seeks ever improved means of measuring the chemical composition of natural and artificial materials.Netupitant Delayed emesis has been largely associated with the activation of tachykinin family neurokinin 1 receptors. Palonosetron is a selective serotonin 5-HT3 receptor antagonist. The antiemetic activity of the drug is brought about through the inhibition of 5-HT3 receptors present both centrally  and peripherally in turn inhibits the visceral afferent stimulation of the vomiting center.The mobile phase used was orthophosphoric and acetate 70% buffer pH 3 and 30% methanol.The assay of Netupitant and Palanosetron was performed with tablets and the % assay was found to be 100.08 and 100.04, The linearity was found to be linear with a correlation coefficient of 0.999, the precision 0.8 and 0.3 for Netupitant and Palanosetron which shows that the method is precise.The validation of developed method shows that the accuracy is well within the limit, which shows that the method is capable of showing good accuracy and reproducibility. The LOD and LOQ for Netupitant were found to be 3.02 and 9.98 and LOD and LOQ for Palanosetron was found to be 3.00 and 10.00. Thus, it shows that the method is stability indicating, sensitive, accurate, robust and precise. Hence, the developed HPLC method can be successfully applied to the pharmaceutical dosage form and can be used for routine analysis.      
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