نتایج جستجو برای: international conference on harmonization
تعداد نتایج: 8548523 فیلتر نتایج به سال:
A simple, sensitive and accurate reversed phase high performance liquid chromatographic method for terbinafine and bezafibrate drugs. This method is developed for terbinafine and bezafibrate drugs. Reversed phase chromatographic separation of the two drugs was performed a C18 column is used with different mobile phases of methanol, water, ammonium dihydrogen phosphate and methanol, acetonitrile...
Objectives: This study aimed to develop simple UV spectrophotometric methods for simultaneous determination of pravastatin sodium and pioglitazone hydrochloride without previous separation. Methods. The first method is the first derivative, where the peak amplitudes of first derivative of absorption spectra were measured at 249.7 and 277 nm for pravastatin sodium and pioglitazone hydrochloride ...
In the present study, comprehensive stress testing of amlodipine (AM) was carried out according to International Conference on Harmonization (ICH) Q1A(R2) guideline. AM was subjected to acidic, neutral and alkaline hydrolysis, oxidation, photolysis and thermal stress conditions. The drug showed instability in acidic and alkaline conditions, while it remained stable to neutral, oxidative, light ...
This study describes the development and validation of stability indicating RP-HPLC method for Mirtazapine, an antidepressant drug. In order to investigate the stability of drug, a stress testing of drug sample by exposing it to variety of forced degradation conditions has been recommended. Mirtazapine was subjected to stress degradation 1 under different conditions recommended by International...
A simple, selective and precise stabilityindicating HPLC method for determination of glabridin diacetate and dihexanoate prodrugs was developed, validated and applied to the enzymatic and chemical hydrolysis studies. The chromatographic separation was achieved on a reverse phase C18 (Thermo Hypersil-Keystone, 250 × 4.6 mm, 5 micron) column using the mixture of acetonitrile and water as mobile p...
AIMS To characterize the effects of levofloxacin on QT interval in healthy subjects and the most appropriate oral positive control treatments for International Conference on Harmonization (ICH) E14 QT/QTc studies. METHODS Healthy subjects received a single dose of levofloxacin (1000 or 1500 mg), moxifloxacin (400 mg) or placebo in a four-period crossover design. Digital 12-lead ECGs were reco...
BACKGROUND The HONEYPOT study is a multicenter, open-label, blinded-outcome, randomized controlled trial designed to determine whether, compared with standard topical application of mupirocin for nasal staphylococcal carriage, exit-site application of antibacterial honey reduces the rate of catheter-associated infections in peritoneal dialysis patients. OBJECTIVE To make public the pre-specif...
A determinação espectroscópica multivariada da associação lamivudina-zidovudina foi realizada por regressão de mínimos quadrados parciais. O modelo foi desenvolvido a partir de 20 misturas sintéticas utilizando-se dados espectrais centrados na média adquiridos entre 190 e 350 nm e 3 variáveis latentes. A validação externa foi realizada a partir de 6 misturas sintéticas, observando-se erros médi...
A glimepirida é um fármaco antidiabético oral usado no tratamento da diabetes tipo 2. Este trabalho propôs o desenvolvimento e validação de um método por espectrofotometria derivada na região do ultravioleta para determinação de glimepirida em comprimidos. A quantificação de glimepirida em solução de NaOH 5×10 mol L foi realizada usando um intervalo de 8 nm entre 220 a 300 nm. Os valores de amp...
Objective (s): This study aimed at investigation of preparation and stability study of Mitomycin and Mitomycin loaded nanoliposems and efficacy of the combination of Mitomycin -loaded nanoliposomes and Curcumin versus Mitomycin in suppressing HTB-9 and L929 cell lines, in vitro.Materials and Methods: An HPLC method was validated based on Q2 (R1) International Conference on Harmonization (ICH) g...
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