A Validated Reversed-Phase HPLC Method for the Determination of Atorvastatin Calcium in Tablets

A Reversed-Phase Liquid Chromatographic (RP-LC) assay method was developed for the quantitative determination of atorvastatin calcium in the presence of its degradation products. The assay involved an isocratic elution of atorvastatin calcium in a LiChroCARTR 250*4 mm HPLC Cartridge LiChrospherR 100 RP-18 (5 μm) column using a mobile phase consisting of 0.1% acetic acid solution: acetonitrile (45:55, v/v), pH = 3.8. The flow rate was 0.8 mL/min and the analytes monitored at 246 nm. The assay method was found to be linear from 8.13 to 23.77 μg/mL. All the validation parameters were within the acceptance range. The developed method was successfully applied to estimate the amount of atorvastatin calcium in tablets.Fil: Simionato, Laura Daniela. Universidad de Buenos Aires. Facultad de Farmacia y Bioquímica. Departamento de Tecnología Farmacéutica; ArgentinaFil: Ferello, L.. Universidad de Buenos Aires. Facultad de Farmacia y Bioquímica. Departamento de Tecnología Farmacéutica; ArgentinaFil: Stamer. S.. Universidad de Buenos Aires. Facultad de Farmacia y Bioquímica. Departamento de Tecnología Farmacéutica; ArgentinaFil: Repetto, M. F.. Universidad de Buenos Aires. Facultad de Farmacia y Bioquímica. Departamento de Tecnología Farmacéutica; ArgentinaFil: Zubata, P. D.. Universidad de Buenos Aires. Facultad de Farmacia y Bioquímica. Departamento de Tecnología Farmacéutica; ArgentinaFil: Segall, Adriana Ines. Universidad de Buenos Aires. Facultad de Farmacia y Bioquímica. Departamento de Tecnología Farmacéutica; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas. Oficina de Coordinación Administrativa Houssay; Argentin

Dissolution Stability study of Cefadroxil extemporaneous suspensions

Dissolution studies have become matter of great significance because, in most cases, drug dissolution is the rate-limiting step in the absorption process. As occurs with solid oral dosage forms, heterogeneous disperse systems (suspensions) could also have some problems with their in vitro dissolution. The dissolution behavior of four different brands of cefadroxil extemporaneous suspensions available in the Argentinian market was evaluated. The deliverable volume, pH, visual appearance, uniformity of dosage units, and assay were also studied. Powders for oral suspension were stored under different aging conditions. Samples at room temperature and refrigerated conditions were taken at several time points to carry out the dissolution stability study during the expiration period of the reconstituted form. Marked differences were recorded with respect to in vitro dissolution behavior between the different products under evaluation.Fil: González Vidal, Noelia Luján. Universidad Nacional del Sur. Departamento de Biología, Bioquímica y Farmacia. Cátedra de Control de Calidad de Medicamentos; Argentina. Universidad Nacional del Sur. Departamento de Biología, Bioquímica y Farmacia. Cátedra de Control de Calidad de Medicamentos; ArgentinaFil: Zubata, P. D.. Universidad de Buenos Aires. Facultad de Farmacia y Bioquímica. Departamento de Tecnología Farmacéutica; ArgentinaFil: Simionato, Laura Daniela. Universidad Nacional del Sur. Departamento de Biología, Bioquímica y Farmacia. Cátedra de Control de Calidad de Medicamentos; Argentina. Universidad de Buenos Aires. Facultad de Farmacia y Bioquímica. Departamento de Tecnología Farmacéutica; ArgentinaFil: Pizzorno, Maria Teresa. Universidad de Buenos Aires. Facultad de Farmacia y Bioquímica. Departamento de Tecnología Farmacéutica; Argentina. Universidad Nacional del Sur. Departamento de Biología, Bioquímica y Farmacia. Cátedra de Control de Calidad de Medicamentos; Argentin

A comparative in vitro assay of drug release performance of pyridostigmine bromide tablets

Myasthenia gravis is an autoimmune disease that destroys key components of the neuromuscular system. The most common therapy uses reversible inhibitors of cholinesterase activity, such as pyridostigmine bromide (PB). The nature of this illness implies that we must be sure that all available PB immediate-release tablets produce the same therapeutic response. The aim of this study was to analyze PB immediate-release formulations provided by pharmacies in MERCOSUR countries A, B, and C. The formulations, which were produced in different manufacturing plants of the same multinational company, were analyzed following USP 29 specifications. The products fulfilled the assay, uniformity of dosage units, and dissolution test in S2 stage. Dissolution profiles were carried out following EMEA and FDA regulations, and the similarity factor (f2) was applied to A and C but not B, as this one did not fulfill the dissolution requirements. Pyridostigmine bromide tablets from countries A and C are considered to be similar and could be interchangeable. Formulation B exhibited such different dissolution behavior that its interchangeability is discouraged, as well as its introduction in countries A and C from the manufacturing country B.Fil: Pizzorno, Maria Teresa. Universidad de Buenos Aires. Facultad de Farmacia y Bioquímica; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas. Oficina de Coordinación Administrativa Houssay; ArgentinaFil: Zubata, Patricia D.. Universidad de Buenos Aires. Facultad de Farmacia y Bioquímica; ArgentinaFil: Simionato, Laura Daniela. Universidad de Buenos Aires. Facultad de Farmacia y Bioquímica; ArgentinaFil: Ercolano, Irma. Universidad de Buenos Aires. Facultad de Farmacia y Bioquímica; ArgentinaFil: Pizzorno, Maria Teresa. Universidad de Buenos Aires. Facultad de Farmacia y Bioquímica; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas. Oficina de Coordinación Administrativa Houssay; Argentin

Similitud e Intercambiabilidad de Formulaciones de Cefalexina

Se ha realizado un estudio de similitud de comprimidos de cefalexina 500 mg sobre cuatro marcas comerciales argentinas, con respecto a una formulación de referencia. El análisis se basó en la evaluación de los perfiles de disolución de dichas especialidades, según los requerimientos de FDA y EMEA, aceptados por ANMAT. Los resultados obtenidos permiten evaluar la similitud entre los productos y facilita la intercambiabilidad de los mismos en el acto de dispensación.Fil: González Vidal, Noelia Luján. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina. Universidad de Buenos Aires. Facultad de Farmacia y Bioquímica; Argentina. Universidad Nacional del Sur; ArgentinaFil: Simionato, Laura Daniela. Universidad de Buenos Aires. Facultad de Farmacia y Bioquímica; ArgentinaFil: Zubata, Patricia. Universidad de Buenos Aires. Facultad de Farmacia y Bioquímica; ArgentinaFil: Pizzorno, Maria Teresa. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina. Universidad de Buenos Aires. Facultad de Farmacia y Bioquímica; Argentina. Universidad Nacional del Sur; Argentin

A Stability Indicating HPLC Method for the Determination of Benzophenone-3 and Avobenzone in Cosmetic Formulations

An accurate, simple, and reproducible liquid chromatographic method was developed and validated for the determination of benzophenone-3 and avobenzone in a cosmetic formulation. The analyses were performed at room temperature on a reverse-phase C18 column (Inerstil ODS-3) (250 4.6 mm, 5 lm). The mobile phase, which consisted of methanol:water (95:5) and pH 3.2 adjusted with 85% of phosphoric acid, was pumped at a constant flow rate of 1 mL=min. Detection was performed on a UV detector at 315 nm. The method was validated in terms of linearity, precision, accuracy, and specificity by forced decomposition of benzophenone-3 and avobenzone using acid, base, water, hydrogen peroxide, heat, and light. The response of was linear in the range 0.08 to 0.24 mg=mL and 0.04 to 0.12 mg=mL for benzophenone-3 (r2 ¼ 0.9984), and avobenzone (r2 ¼ 0.9925), respectively. The relative standard deviation values for intra- and inter-day precision studies were 0.81 and 0.91 for benzophenone-3 and 1.57 and 1.13 for avobenzone. Recoveries ranged between 99.58 and 101.39 for benzophenone-3 and 98.63 and 102.05 for avobenzone.Fil: Ceresole, Rita. Universidad de Buenos Aires. Facultad de Farmacia y Bioquímica. Departamento de Tecnología Farmacéutica; Argentina;Fil: Han, Yong K.. Universidad de Buenos Aires. Facultad de Farmacia y Bioquímica; Argentina;Fil: Simionato, Laura Daniela. Universidad de Buenos Aires. Facultad de Farmacia y Bioquímica. Departamento de Tecnología Farmacéutica; Argentina;Fil: Segall, Adriana Ines. Universidad de Buenos Aires. Facultad de Farmacia y Bioquímica. Departamento de Tecnología Farmacéutica; Argentina

Un vomito tanto precoce: la spia di un'atresia intestinale

N/

Validation of Liquid Chromatographic Method for Analysis of Tacrolimus in a Pharmaceutical Dosage Form

An accurate, simple and reproducible liquid chromatographic method was developed and validated for the determination of  tacrolimus in capsules. The analysis were performed at room temperature on a reverse phase C18 column with UV detection at 210 nm. The mobile phase consisted of  methanol-water (90 + 10) at a constant flow rate of 0.8 mL/min. The method was validated in terms of linearity, precision, accuracy and specificity by forced decomposition of tacrolimus using acid, base, water, hydrogen peroxide, heat and light. The response was linear in the range of 0.09-0.24  mg/mL (r2 = 0.9997). The relative standard deviation values for intra- and interday precision studies were 1.28 and 2.91.  Recoveries ranged between 98.06 and 102.52 %.Fil: Moyano, Maria Alejandra. Universidad de Buenos Aires. Facultad de Farmacia y Bioquímica; ArgentinaFil: Simionato, Laura Daniela. Universidad de Buenos Aires. Facultad de Farmacia y Bioquímica; ArgentinaFil: Pizzorno, Maria Teresa. Universidad de Buenos Aires. Facultad de Farmacia y Bioquímica; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas. Oficina de Coordinación Administrativa Houssay; ArgentinaFil: Segall, Adriana Ines. Consejo Nacional de Investigaciones Científicas y Técnicas. Oficina de Coordinación Administrativa Houssay; Argentina. Universidad de Buenos Aires. Facultad de Farmacia y Bioquímica; Argentin

More than (Double) Bubble

N.A

Comparison of Dissolution Profiles of Furosemide Tablets Available in the Argentinean Market

In this work dissolution profiles of furosemide tablets of nine commercial products marketed in Argentine were evaluated. All brands fulfill the specifications of dissolution test of USP. Comparison of dissolution profiles were carried out by model-dependent and model independent approaches. Results obtained via model-dependent approach show a first order drug release mechanism especially for Brand I (reference) and Brand IV. Results obtained via modelindependent approach show that there was not significant difference in Dissolution efficiency between the reference product and Brands II, III and IV and in Mean dissolution time between the reference product and Brands II, III, IV and V. Using fit factors, only Brands I and III were similar.Fil: Han, Yong Ki. Universidad de Buenos Aires. Facultad de Farmacia y Bioquímica; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas. Oficina de Coordinación Administrativa Houssay; ArgentinaFil: Simionato, Laura Daniela. Universidad de Buenos Aires. Facultad de Farmacia y Bioquímica; ArgentinaFil: Calvo, Romina G.. Universidad de Buenos Aires. Facultad de Farmacia y Bioquímica; ArgentinaFil: Mattei, María Belén. Universidad de Buenos Aires. Facultad de Farmacia y Bioquímica; ArgentinaFil: Segall, Adriana Ines. Universidad de Buenos Aires. Facultad de Farmacia y Bioquímica; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas. Oficina de Coordinación Administrativa Houssay; Argentin

A Comparative Analysis of Dissolution Profiles of Furosemide Tablets Available in the Argentinean Market (Part 2)

The rate and the extent of drug dissolution and its absorption depend on the characteristics of the active pharmaceutical ingredient (API) as well as the dosage form properties. In this work dissolution profiles of furosemide tablets of nine commercial products marketed in Argentine were evaluated. All Brands fulfill the specifications of dissolution test of USP. Comparison of dissolution profiles were carried out by model-dependent and model independent approaches. The Weibull model provided the best kinetic curve adjustment. Brands IV, VI and IX had the best fitting, with the maximum determination coefficient and the smallest AIC values. Results obtained via model-independent approach show that there was not significative difference in Dissolution efficiency between the reference product and Brands II, III and IV and in Mean dissolution time between the reference product and Brands II, III, IV and V. Using fit factors, only Brands I and III were similar. It has been demonstrated in vivo bioequivalence of furosemide market products interchangeability with generics should be avoided.Fil: Han, Yong Ki. Universidad de Buenos Aires. Facultad de Farmacia y Bioquímica. Departamento de Tecnología Farmacéutica; ArgentinaFil: Simionato, Laura Daniela. Universidad de Buenos Aires. Facultad de Farmacia y Bioquímica. Departamento de Tecnología Farmacéutica; ArgentinaFil: Calvo, Romina Giselle. Universidad de Buenos Aires. Facultad de Farmacia y Bioquímica. Departamento de Tecnología Farmacéutica; ArgentinaFil: Mattei, M. Belén. Universidad de Buenos Aires. Facultad de Farmacia y Bioquímica. Departamento de Tecnología Farmacéutica; ArgentinaFil: Segall, Adriana Ines. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina. Universidad de Buenos Aires. Facultad de Farmacia y Bioquímica. Departamento de Tecnología Farmacéutica; Argentin