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VALIDATION: 作品数：999被引量：2161H指数：20; 导出分析报告; 相关领域：医药卫生更多>>; 相关作者：刘慧芹李强苏伟聂宜民张建国更多>>; 相关机构：北京大学中山大学中国科学院中国科学院大气物理研究所更多>>; 相关期刊：更多>>; 相关基金：国家自然科学基金国家重点基础研究发展计划国家高技术研究发展计划中国博士后科学基金更多>>

Solriamfetol impurities:Synthesis,characterization,and analytical method(UPLC-UV)validation: 《Journal of Pharmaceutical Analysis》2023年第4期403-411,共9页Nafisah Al-Rifai Anas Alshishani Fouad Darras Ola Taha Shereen Abu-Jalloud Lena Shaghlil Yousef Al-Ebini; This research was funded by the Deanship of Scientific Research at the German-Jordanian University and the Deanship of Scientific Research at Zarqa University.The graphical abstract was created with BioRender software.; Given that impurities may affect the quality and safety of drug products,impurity identification and profiling is an integral part of drug quality control and is particularly important for newly developed medications ...; 关键词：Solriamfetol Impurity analysis Impurity synthesis UPLC Method validation

Analysis of docosanol using GC/MS:Method development,validation,and application to ex vivo human skin permeation studies: 《Journal of Pharmaceutical Analysis》2022年第2期287-292,共6页Vijay Kumar Shankar Mei Wang Srinivas Ajjarapu Praveen Kolimi Bharathi Avula Reena Murthy Ikhlas Khan Sathyanarayana Narasimha Murthy; Docosanol is the only US Food and Drug Administration(FDA)approved over-the-counter topical product for treating recurrent oral-facial herpes simplex labialis.Validated analytical methods for docosanol are required to...; 关键词：Docosanol Fatty alcohols Gas chromatography-mass spectrometry Topical formulation Skin permeation

Development and validation of a stability-indicating RP–HPLC method for estimation of atazanavir sulfate in bulk: 《Journal of Pharmaceutical Analysis》2017年第2期134-140,共7页S.Dey S.Subhasis Patro N.Suresh Babu P.N.Murthy S.K.Panda; A stability-indicating reverse phase–high performance liquid chromatography（RP–HPLC） method was developed and validated for the determination of atazanavir sulfate in tablet dosage forms using C_（18） column Phen...; 关键词：Atazanavir sulfate RP–HPLC Isocratic elution Validation Stability indicating

Validation of a liquid chromatographic method for the pharmaceutical quality control of products containing elacridar: 《Journal of Pharmaceutical Analysis》2016年第4期268-275,共8页Emilia Sawicki Michel J.Hillebrand Hilde Rosing Jan H.M.Schellens Bastiaan Nuijen Jos H.Beijnen; Many anticancer drugs have an impaired bioavailability and poor brain penetration because they are substrates to drug efflux pumps such as P-glycoprotein and Breast Cancer Resistance Protein.Elacridar is a strong inhi...; 关键词：GF120918 Solid dispersion Dissolution Hydroxylation HPLC-UV

Development and validation of a high throughput UPLC–MS/MS method for simultaneous quantification of esomeprazole,rabeprazole and levosulpiride in human plasma被引量：2: 《Journal of Pharmaceutical Analysis》2016年第3期190-198,共9页Raja Haranadha Babu Chunduri Gowri Sankar Dannana; A high throughput ultra pressure liquid chromatography-mass spectrometry （UPLC-MS/MS） method with good sensitivity and selectivity has been developed and validated for simultaneous quantification of esomeprazole, ra...; 关键词：ESOMEPRAZOLE RABEPRAZOLE Levosulpiride UPLC-MS/MS Pharmacokinetic studies

Development and validation of a GC–FID method for quantitative analysis of oleic acid and related fatty acids被引量：6: 《Journal of Pharmaceutical Analysis》2015年第4期223-230,共8页Honggen Zhang Zhenyu Wang Oscar Liu; Oleic acid is a common pharmaceutical excipient that has been widely used in various dosage forms. Gas chromatography （GC） has often been used as the quantitation method for fatty acids normally requiring a derivati...; 关键词：Oleic acidFatty acidsGas chromatographyMethod developmentDerivatization-ffee

Identification, synthesis and characterization of process related impurities of benidipine hydrochloride, stress-testing/stability studies and HPLC/UPLC method validations被引量：2: 《Journal of Pharmaceutical Analysis》2015年第4期256-268,共13页Esen Bellur Atici Bekir Karl??a; the management of Deva Holding A.S., Istanbul, Turkey, for supporting this work;the Scientific and Technological Research Council of Turkey (TUBITAK-TEYDEB Project no: 3110426) for the financial support; Benidipine hydrochloride, used as an antihypertensive agent and long-acting calcium antagonist, is synthesized for commercial use as a drug substance in highly pure form. During the synthetic process development studi...; 关键词：Benidipine Impurities Synthesis Characterization Validation Stability

Liquid chromatography/tandem mass spectrometry method for quantitative estimation of solutol HS15 and its applications被引量：1: 《Journal of Pharmaceutical Analysis》2015年第2期120-129,共10页V.Vijaya Bhaskar Anil Middha Pratima Srivastava Sriram Rajagopal; A rapid, sensitive and selective pseudo MRM（p MRM）-based method for the determination of solutol HS15（SHS15） in rat plasma was developed using liquid chromatography/tandem mass spectrometry（LC–MS/MS）. The most ...; 关键词：SHS15 LC–MS/MS Spiky profiles Validation

Development and validation of microbial bioassay for quantification of Levofloxacin in pharmaceutical preparations被引量：1: 《Journal of Pharmaceutical Analysis》2015年第1期18-26,共9页Nishant A.Dafale Uttam P.Semwal Piyush K.Agarwal Pradeep Sharma G.N.Singh; The aim of this study was to develop and validate a simple,sensitive,precise and cost-effective onelevel agar diffusion（5＋1） bioassay for estimation of potency and bioactivity of Levofioxacin in pharmaceutical prep...; 关键词：Levofloxacin Antibiotic resistance Microbiological bioassay HPLC Pharmacopoeia

Optimization and validation of a fast RP-HPLC method for the determination of dobutamine in rat plasma:Pharmacokinetic studies in healthy rat subjects: 《Journal of Pharmaceutical Analysis》2013年第6期434-439,共6页Ramesh Thippani Nageswara Rao Pothuraju Nageswara Rao Ramisetti Saida Shaik; Mr.Thippani Ramesh thanks MHRD,Government of India for providing financial assistance; A novel isocratic reverse phase high performance liquid chromatography （RP-HPLC） with photo diode array （PDA） detection method for the determination of dobutamine （DBT） in rat plasma was developed and validated ...; 关键词：DOBUTAMINE RP-HPLC VALIDATION Rat plasma PHARMACOKINETICS

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