نتایج جستجو برای: international conference on harmonization
تعداد نتایج: 8548523 فیلتر نتایج به سال:
A novel stability-indicating normal phase liquid chromatographic (NP-LC) method was developed for the determination of purity of naproxcinod in the presence of its impurities and degradation products. This method is capable of separating all the related substances of naproxcinod along with its chiral and achiral impurities. This method can be also be used for the estimation of assay of naproxci...
The objective of the current study was to develop a validated, specific and stability-indicating reverse phase liquid chromatographic method for the quantitative determination of fluocinonide and its related substances. The determination was done for active pharmaceutical ingredient and its pharmaceutical dosage forms in the presence of degradation products, and its process-related impurities. ...
BACKGROUND Repaglinide is a miglitinide class of antidiabetic drug used for the treatment of type 2 diabetes mellitus. A fast and reliable method for the determination of repaglinide was highly desirable to support formulation screening and quality control. OBJECTIVE UV spectrophotometric and reversed-phase high performance liquid chromatography (RP-HPLC) methods were developed for determinat...
The ninth month of Islamic calendar is known as Ramadan, in which fasting is obligatory for every adult man and woman, except in certain health conditions and during travelling. Since Islamic jurisprudence follows the lunar calendar, which is about 11 days shorter than the Gregorian, Ramadan falls in different seasons throughout the year. The duration of fasting hence may differ by 11 to 18 hou...
The purpose of this research work was to develop a novel, sensitive and accurate analytical method for quantification of 12 residual solvents in Dapagliflozin Amorphous by using a static headspace gas chromatography (HSGC) coupled with flame ionization detector (FID). Methanol, Ethanol, Diethyl ether, Methyl acetate, Dichloromethane, Ethyl acetate, Tetrahydrofuran, Cyclohexane, Isopropyl acetat...
High performance liquid chromatographic method was developed valdated and applied for the simultaneous determination of lisinopril and NSAIDs in bulk, pharmaceuticals formulations and human serum. A Purospher star C18 (5 μm, 25 × 0.46 cm) column was used with mobile phase consisting of methanol: water: acetonitrile (80:17.5:2.5 v/v, pH 3.0) and quantitative evaluation was performed at 225 nm wi...
Method validation is an important requirement for any package of information submitted to international regulatory agencies in support of new product marketing or clinical trials applications. Analytical methods should be validated, including methods published in the relevant pharmacopoeia or other recognized standard references. The suitability of all test methods used should always be verifie...
The novel reverse phase-high performance liquid chromatography (RP-HPLC), stability indicating method was developed for determination of linagliptin (LGP) and its related substances in linagliptin and metformin HCl (MET HCl) tablets by implementing design of experiment to understand the critical method parameters and their relation with critical method attributes; to ensure robustness of the me...
The chromatographic analysis was performed on ODS symmetry C18 column (150 × 4.6 mm, 5 μ particle size) with mobile phase consisting of acetonitrile and phosphate buffer (pH 4.0) in the ratio of 60:40 v/v, at a flow rate of 1.2 mL/min and eluents monitored at 237 nm. The method was validated for linearity, accuracy, precision, robustness and application for assay as per International Conference...
A reversed-phase liquid chromatographic (RP-HPLC) method was developed for the simultaneous determination of tolperisone hydrochloride (TOLP) and etodolac (ETD) in a combined fixed dose oral formulation. The analysis was carried out using a phenomenax C-18, pre-packed column. A mobile phase containing a phosphate buffer (pH 5.5) : Methanol : Acetonitrile : Tri-ethylamine (40 : 40 : 20 : 1.5), w...
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