Authors:V. P. Rane, K. R. Patil, J. N. Sangshetti, R. D. Yeole, and D. B. Shinde
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.
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 dosageforms containing OLZ.
In this study, DSC, TG, and XRPD techniques were applied with the
Authors:Géza Regdon Jr., Diána Hegyesi, and Klára Pintye-Hódi
investigation of the stability of the preparations. Thermoanalysis is a very well used method in the preformulation tests of solid dosageforms [ 2 – 7 ].
There are some publications in literature on the thermoanalytical examination of free films or film
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 dosageforms. For this purpose a hyphenated technique for simultaneous TG/DTG/HF/EGA determinations was used. In order to assess the excipients
Authors:Nafiu Aminu, Siok-Yee Chan, Nasir Hayat Khan, Ahmed Bassam Farhan, Muhammad Nura Umar, and Seok-Ming Toh
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 dosageform that is widely used for fixed
Authors:P. R. Desai, P. J. Mehta, S. K. Ojha, and A. B. Chokshi
determination of related substances of ezetimibe and simvastatin in combined dosageforms. 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