反相高效液相色谱(rp-hplc)同时测定盐酸氮唑elastine、丙酸氟替卡松和苯乙醇在dymista (meda)鼻喷雾剂中的含量

IF 0.5 Q4 EDUCATION & EDUCATIONAL RESEARCH

Rasayan Journal of Chemistry Pub Date : 2023-01-01 DOI:10.31788/rjc.2023.1616916

A. Gupta, P. Singour, S. K. Jain

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引用次数: 0

摘要

本工作报道了反相高效液相色谱法定量测定鼻喷雾剂制剂中盐酸氮杂松碱、丙酸氟替卡松和苯乙醇的含量。实验采用Intersil十八烷基硅烷(C18)色谱柱(25 cm × 4.6 mm × 5 μm)，流动相为缓冲液:溶剂混合物(40:60 %v/v)，用稀正磷酸调节pH至6.5，等密度洗脱这些成分。流速为1.4 mLmin-1，检测波长为254 nm。分离在20分钟内完成。盐酸氮扎elastine、丙酸氟替卡松和苯乙醇在50%、75%、100%、125%和150%的浓度范围内均呈线性，相关系数大于0.99。该方法的准确度在50 ~ 150%之间，加标安慰剂的活性回收率为98 ~ 102%。结果表明，该方法精度高，系统重现性和方法重现性均可接受。所有验证参数均在国际协调会议规范的可接受范围内。该方法简便、快速，可用于配方的常规估算。

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SIMULTANEOUS REVERSE PHASE-HIGH PERFORMANCE LIQUID CHROMATOGRAPHY (RP-HPLC) ESTIMATION OF AZELASTINE HYDROCHLORIDE, FLUTICASONE PROPIONATE, AND PHENYL ETHYL ALCOHOL IN DYMISTA (MEDA) NASAL SPRAY

This work reported a reverse phase-high performance liquid chromatography method for quantitative estimation of Azelastine Hydrochloride, Fluticasone Propionate, and Phenylethyl Alcohol in Nasal Spray formulation. The assay involved an isocratic elution of these components by using Intersil Octadecylsilane (C18) column (25 cm x 4.6 mm x 5 μm) using mobile phase composition of Buffer: Solvent Mixture (40:60 %v/v) and pH adjusted to 6.5 with dilute orthophosphoric acid. The flow rate was 1.4 mLmin-1 and the analytes are monitored at 254 nm. Separation was completed within 20 minutes. Calibration curves were linear with correlation coefficient more than 0.99 over a concentration range of 50%, 75%, 100%, 125%, and 150% for Azelastine Hydrochloride, Fluticasone Propionate and Phenylethyl Alcohol. The method was proven to be accurate between 50 to 150% with 98 to 102 % recovery of the actives from a spiked placebo. The method was shown to be precise yielding acceptable results for the system reproducibility and method repeatability. All the validation parameters were within the acceptance range according to International Conference on Harmonization norms. The developed method is simple and rapid which could be applied for routine estimation of the formulation.

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来源期刊

Rasayan Journal of Chemistry Energy-Energy (all)

CiteScore

1.90

自引率

0.00%

发文量

196

期刊介绍： RASĀYAN Journal of Chemistry [RJC] signifies a confluence of diverse streams of chemistry to stir up the cerebral powers of its contributors and readers. By introducing the journal by this name, we humbly intent to provide an open platform to all researchers, academicians and readers to showcase their ideas and research findings among the people of their own fraternity and to share their vast repository of knowledge and information. The journal seeks to embody the spirit of enquiry and innovation to augment the richness of existing chemistry literature and theories. We also aim towards making this journal an unparalleled reservoir of information and in process aspire to inculcate and expand the research aptitude.