萘普生
色谱法
高效液相色谱法
化学
乙腈
体积流量
醋酸
洗脱
分析化学(期刊)
医学
替代医学
病理
量子力学
生物化学
物理
作者
Ch. V Kameswara Rao,K Ramakrishna,V D N Kumar Abbaraju
出处
期刊:Ymer
日期:2022-06-22
卷期号:21 (06): 710-722
标识
DOI:10.37896/ymer21.06/72
摘要
A validated HPLC method was developed for the determination of Naproxen in pharma formulation. Isocratic elution at a flow rate of 1.0 ml/min was employed on NOVAPAK C18 4μm (3.9 x 150 mm) or equivalent, or similar is used for this chromatography analysis. Acetonitrile as 500v/v, water as 490 v/v furthermore Glacial Acetic acid as 10v/v is used a mobile phase. The UV detection wavelength was 254nm and 10.0µl sample was injected. The run time is About 120minutes for Sample, Unmarked, Placebo, System suitability, Sensitivity solution and 60minutes for diluted Regular. The Approximate retention time was founded for Naproxen is ± 3 minutes. The% R.S.D Naproxen was identified. The mean Percentage recovery for Naproxen is found within the specification limit. The method was validated as per the ICH guidelines. Thus, the proposed HPLC method can be successfully applied for routine quality control analysis of formulations. This method developed is simple and is better than the methods reported in the literature. Key words: RP-HPLC Refractive index detector, Naproxen, flow rate, column, ICH Guidelines, USP reference
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