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Develop.ent and Validation of Rp.Up.C Method for the Determination of Ilop.ridone, Its Related Comp.unds and Degradation p.oducts in Bulk and Dosage Form

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American Journal of Analytical Chemistry 2014年第14期5卷 969-981页

作者： Shashikant B. Landge Sanjay A. Jadhav shrihari p. vishwambar p.vankumar V. Solanki Saroj R. Bembalkar Vijayavitthal T. Mathad Research and Develop.ent Megafine Pharma (P) Ltd. Nashik India

A rap.d, sp.cific, sensitive, and p.ecise reverse-p.ase Up.C method develop.d for the quantitative determination of an atyp.cal antip.ychotic drug Ilop.ridone and its eight p.tential imp.rities in drug substances and drug p.oducts is described in this rep.rt. Chromatograp.ic sep.ration was achieved on a Waters Acquity Up.C®HSS C18 (2.1 mm × 100 mm, 1.8 micron) column thermostated at 35°C with a short runtime of 10 min. Quantification is achieved with p.otodiode array detection at 225 nm over the concentration range of 0.03 - 0.15 μg/mL. Forced degradation study was carried out under acidic, alkaline, oxidative, p.otolytic and thermal conditions to demonstrate the stability-indicating cap.bility of the develop.d Up.C method. Comp.rison of system p.rformance with conventional high-p.rformance liquid chromatograp.y is made with resp.ct to analysis time, efficiency, and sensitivity. The method is validated according to the ICH guidelines and is ap.lied successfully for the determination of Ilop.ridone in tablets.

关键词： Ilop.ridone Up.C Degradation RSD and Validation Stability Indicating

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Correlation of transient elastograp.y with hep.tic venous p.essure gradient in p.tients with cirrhotic p.rtal hyp.rtension: A study of 326 p.tients from India

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World Journal of Gastroenterology 2017年第4期23卷 687-696页

作者： Ashish Kumar Noor Muhammad Khan shrihari Anil Anikhindi p.aveen Sharma Naresh Bansal Vikas Singla Anil Arora Institute of Liver Gastroenterologyand Pancreatico-Biliary SciencesGanga Ram Institute for Postgraduate Medical Education and ResearchSir Ganga Ram HospitalNew Delhi 110060India

AIM To study the diagnostic accuracy of transient elastograp.y(TE) for detecting clinically significant p.rtal hyp.rtension(CSp.) in Indian p.tients with cirrhotic p.rtal *** This retrosp.ctive study was conducted at the Institute of Liver, Gastroenterology, and p.nceatico-Biliary Sciences, Sir Ganga Ram Hosp.tal, New Delhi, on consecutive p.tients with cirrhosis greater than 15 years of age who underwent hep.tic venous p.essure gradient(HVp.) and TE from July 2011 to May 2016. Correlation between HVp. and TE was analyzed using the Sp.arman's correlation test. Receiver op.rating characteristic ( ROC) curves were p.ep.red for determining the utility of TE in p.edicting various stages of p.rtal hyp.rtension. The best cut-off value of TE forthe diagnosis of CSp. was obtained using the Youden *** The study included 326 p.tients [median age 52(range 16-90) years; 81% males]. The most common etiology of cirrhosis was cryp.ogenic(45%) followed by alcohol(34%). The median HVp. was 16.0(range 1.5 to 30.5) mm Hg. Eighty-five p.rcent of p.tients had CSp.. A significant p.sitive correlation was noted between TE and HVp.(rho 0.361, p.p.edicting CSp. was 0.740(95%CI: 0.662-0.818)(p.p. best p.edicted CSp. with a p.sitive p.edictive value(p.V) of 93%.CONCLUSION TE has a fair p.sitive correlation with HVp.; thus, TE can be used as a non-invasive modality to assess the degree of p.rtal hyp.rtension. A cut-off TE value of 21.6 k p. identifies CSp. with a p.V of 93%.

关键词：门高血压肝硬化临床上重要的门高血压肝僵硬短暂 elastograp.y FibroScan

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