Search Results

You are looking at 1 - 10 of 245 items for :

  • "dosage form" x
  • All content x
Clear All

Summary

A novel stability-indicating reversed-phase (RP) HPLC method has been developed and validated for quantitative analysis of eplerenone in the bulk drug and in a pharmaceutical dosage form. Use of a 250 mm × 4.6 mm, 5-μm particle, C18 column with 55:45 (v/v) 50 mM ammonium acetate buffer (pH 7)-acetonitrile as isocratic mobile phase enabled separation of the drug from its degradation products. UV detection was performed at 240 nm. The method was validated for linearity, accuracy (recovery), precision, specificity, and robustness. The linearity of the method was excellent over the range 10–100 μg mL−1 (correlation coefficient 0.999). The limits of detection and quantification were 0.019 and 0.053 μg mL−1, respectively. Recovery of eplerenone from the pharmaceutical dosage form ranged from 100.97 to 101.25%. Eplerenone was subjected to stress conditions (hydrolysis (acid, base), oxidation, photolysis, and thermal degradation) and the stressed samples were analysed by use of the method. Degradation was observed in acid, base, and 30% H2O2. The drug was stable under the other stress conditions investigated. The degradation products were well resolved from main peak. The forced degradation studies prove the stability indicating power of the method.

Restricted access
Journal of Thermal Analysis and Calorimetry
Authors: Marco Júnio Peres-Filho, Marilisa Pedroso Nogueira Gaeti, Stela Ramirez de Oliveira, Ricardo Neves Marreto, and Eliana Martins Lima

there have been numerous reports on OLZ polymorphism, there are no literature reports regarding preformulation studies to support the design of solid dosage forms containing OLZ. In this study, DSC, TG, and XRPD techniques were applied with the

Restricted access
Acta Chromatographica
Authors: Effat Souri, Siavash Mottaghi, Mohammad Zargarpoor, Reza Ahmadkhaniha, and Hassan Jalalizadeh

Testing of Immediate Release Solid Oral Dosage Forms , Food and Drug Administration , Rockville, MD , 1997 [11] K. Takacs-Novak , V. Szoke , G

Open access

investigation of the stability of the preparations. Thermoanalysis is a very well used method in the preformulation tests of solid dosage forms [ 2 – 7 ]. There are some publications in literature on the thermoanalytical examination of free films or film

Restricted access
Journal of Thermal Analysis and Calorimetry
Authors: Corina Duda-Seiman, T. Vlase, Gabriela Vlase, Rodica Cinca, Mariana Anghel, and N. Doca

and the excipients—talc (T), magnesium stearate (M), starch (S), and cellulose (C), commonly used in solid dosage forms. For this purpose a hyphenated technique for simultaneous TG/DTG/HF/EGA determinations was used. In order to assess the excipients

Restricted access

. [10] B. Seshamamba , P. Venkata , Application of stability indicating HPLC method with UV detector to the analysis of rivaroxaban in bulk and tablet dosage form , Chem

Restricted access

Thermal analysis techniques, DSC and TG can advantageously be used in quality control of drug products.

Restricted access

more effective than PCM alone in the treatment of a headache induced by tension [ 14 ], and the mild analgesic effect of CF synergistically enhances the action of PCM [ 15 ]. Tablet is a prominent dosage form that is widely used for fixed

Open access

determination of related substances of ezetimibe and simvastatin in combined dosage forms. All the degradation products were well separated from the drug substance, demonstrating the stability-indicating nature of the proposed method. The RP-HPLC method is

Open access

, N.K. Rao , V.B. Kiran , Development and validation of reverse phase RP-HPLC method for the determination of metformin HCl in pharmaceutical dosage forms , Asian J. Chem. 24 ( 2012 ) 5460 – 5462 . [6

Restricted access