Validación del método analítico aplicable al estudio de estabilidad de risperidona solución oral 1 mg/mL / Validation of an analytical method applicable to study of 1 mg/mL oral Risperidone solution stability

Se validó un método analítico por cromatografía líquida de alta resolución, aplicable al estudio de estabilidad de risperidona solución oral 1 mg/mL. El método analítico validado resultó lineal, preciso, específico y exacto. Se desarrolló el estudio de estabilidad de la solución oral de risperidona 1 mg/mL y se determinó su fecha de vencimiento. El estudio de vida de estante se desarrolló por un periodo de 24 meses a temperatura ambiente; mientras que el estudio de estabilidad acelerada se efectuó sometiendo el producto a la influencia de la humedad y la temperatura; se realizó el análisis durante 3 meses. La formulación cumplió con las especificaciones de calidad descritas en la Farmacopea. Los resultados del estudio de estabilidad por vida de estante después de transcurridos los 24 meses indicaron que el producto mantiene los parámetros que determinan su calidad durante ese tiempo, y en los estudios acelerados no se observó degradación significativa (p> 0,05) del producto. Se estableció 2 años como fecha de vencimiento en las condiciones señaladas

A validated analytical method by high-performance liquid chromatography (HPLC) was applicable to study of 1 mg/mL Risperidone oral solution stability. The above method was linear, accurate, specific and exact. A stability study of the 1 mg/mL Risperidone oral solution was developed determining its expiry date. The shelf life study was conducted for 24 months at room temperature; whereas the accelerated stability study was conducted with product under influence of humidity and temperature; analysis was made during 3 months. Formula fulfilled the quality specifications described in Pharmacopeia. The results of stability according to shelf life after 24 months showed that the product maintains the parameters determining its quality during this time and in accelerated studies there was not significant degradation (p> 0.05) in the product. Under mentioned conditions expiry date was of 2 years

Evaluación comparativa de la liberación in vitro de risperidona 3 mg producida en Cuba contra Risperdal® / Comparative assessment of in vitro release of 3 mg Risperidone produced in Cuba versus Risperidal®

Se compararon los perfiles de disolución de las tabletas de risperidona 3 mg medicamento genérico producido en Cuba y del Risperdal® (Laboratorios Janssen-Cilag SA), para demostrar su similitud. También se realizó la comparación en varios medios de disolución a diferentes pH para evaluar una posible bioexoneración. Para la cuantificación del principio activo, se utilizó un método por cromatografía líquida de alta resolución, previamente validado. La comparación se realizó sobre la base de los factores de diferenciación y similitud. Los resultados mostraron que no existían diferencias en los perfiles de liberación para las tabletas producidas en Cuba y del producto innovador, así como para los diferentes medios de disolución a los pH utilizados.

The 3 mg Risperidone tablets dissolution profiles, a generic drug produced in Cuba and the Risperidal® (Janssen-Cilag SA Labs) were compared to demonstrate its similarity. Also, we compared some dissolution means at different pH to assess a potential bio-exoneration. To quantify the active principle, a previously validated high-performance liquid chromatography was used. The comparison was conducted on the base of differentiation and similarity factors. Results demonstrated that there weren't differences en release profiles for tablets produced in Cuba and of innovative product, as well as for the different dissolution means at pH used.

Estudio de estabilidad de tabletas de risperidona 3 mg / Study of stability of Risperidone (3 mg) tablets

Se desarrolló el estudio de estabilidad de las tabletas de risperidona 3 mg y se determinó su fecha de vencimiento. Este estudio se realizó por los métodos de vida de estante y de estabilidad acelerada mediante cromatografía líquida de alta eficiencia, validados en el Centro de Investigación y Desarrollo de Medicamentos. El estudio de vida de estante se desarrolló por un periodo de 24 meses a temperatura ambiente; mientras que el estudio de estabilidad acelerada se efectuó sometiendo el producto a la influencia de la luz, la humedad y la temperatura; se realizó el análisis durante 3 meses, para los 2 primeros y durante 6 meses para el estudio de la temperatura. La formulación de risperidona tabletas 3 mg cumplió con las especificaciones de calidad descritas en la Farmacopea. Los resultados del estudio de estabilidad por vida de estante después de transcurridos los 24 meses indican que el producto mantiene los parametros que determinan su calidad durante ese tiempo, y en los estudios acelerados no se observó degradación del producto. Se estableció 2 años como fecha de vencimiento en las condiciones señaladas.

Stability study was conducted of 3 mg Risperidone tablets determining its caducity date and using the shelf life methods and of accelerated stability by high-performance liquid chromatography validated in Drug Development and Research Center. The shelf life study was developed during 24 months at room temperature; whereas the accelerated stability study was performed subjecting the product to light, humidity and temperature influence. The 3 mg Risperidone tablets formula fulfilled the quality specifications described in Pharmacopeia. Results from shelf life study after 24 months show that the product maintains the parameters determining its quality during that time and in accelerated studies product degradation was noted. Under conditions signaled 2 years was established as the expiry date.

Spectrophotometric determination of mianserin and risperidone

Simple and sensitive spectrophotometric methods were described for the determination of two drugs; namely, mianserin and risperidone, with n-donating groups. The methods were based mainly on charge transfer complexation reactions, with two acceptors 2,3-dichloro-5,6-dicyano benzoquinone [DDQ] and p-chloranilic acid [p-CA], and ion pair complexation reactions with some acidic dyes, namely, bromophenol blue [BPB], bromothymol blue [BTP] and bromocresol green [BCG]. In the first procedure the drugs were treated with DDQ or p-CA in acetonitrile, the colored products were quantified spectrophotometrically at 587 nm and 520 nm for mianserin and 457 nm and 520 nm for risperidone using DDQ and p-chloranilic acid, respectively. In the second procedure drugs were treated with acidic dyes in chloroform, the complexes formed are measured at 411 nm, 411 nm and 414 nm in case of mianserin and 415 nm, 415 nm and 419 nm for risperidone with BPB, BTB and BCG, respectively. The effect of several variables affecting color development was studied and the molar ratio of reactants was established in each case. Linearity ranges were found to be 12-55 mug ml-1, 40-200 mug ml-1, 2-10 mug ml-1, 2.5-12 mug ml-1 and 3-12 mug ml-1 for mianserin and 25-135 mug ml-1, 40-220 mug ml-1, 3.5-15 mug ml-1, 4-18 mug ml-1 and 4-18 mug ml-1 for risperidone using DDQ, p-chloranilic acid, BPB, BTB and BCG, respectively. The proposed methods were applied successfully for the analysis of both drugs in raw material and in pharmaceutical dosage forms with good accuracy and precision. The results were compared statistically with reference methods commonly used for the determination of the drugs