ABSTRACT
En la Farmacopea de los Estados Unidos se orienta como valorar el clorhidrato de ranitidina en una solución inyectable pero cuando se intentó reproducir esta monografía, la ranitidina no se adsorbió a una columna similar a la recomendada. El objetivo del presente trabajo fue validar un método alternativo para la cuantificación de clorhidrato de ranitidina en una solución inyectable. El método alternativo empleado fue el descrito en la Farmacopea de los Estados Unidos para la cuantificación del clorhidrato de ranitidina (la sustancia activa), con modificaciones. La validación del método se realizó siguiendo las indicaciones de la Guía Q2(R1) de la Conferencia Internacional sobre la Armonización. Además se determinó la incertidumbre del método. Los coeficientes de variación obtenidos para la precisión intermedia fueron inferiores a 1,0 %; en la exactitud el recobrado fue de 100,30 % y en la linealidad se demostró la ausencia de curvatura en el intervalo 80 a 120 %. La incertidumbre expandida calculada fue inferior al 2 % de la concentración presente en las muestras. Todos los parámetros de validación evaluados se encontraron dentro los límites de aceptación establecidos por lo que se concluye que el método es adecuado para los fines propuestos.
The United States Pharmacopeia instructs for the determination of ranitidine hydrochloride in an injectable solution but when we tried to reproduce this monograph, the ranitidine was not adsorbed in a similar column as the recommended. The aim of the present work was to validate an alternate method for the determination of ranitidine hydrochloride in an injectable solution. The alternate method was the one described in the United States Pharmacopeia for the determination of ranitidine hydrochloride (active pharmaceutical ingredient), with modifications. The method was validated as per Q2(R1) Guideline, of the International Conference on Harmonization. Method´s uncertainty was also determined. The coefficient of variation obtained for intermediate precision was less than 1.0 %; in the accuracy, the recovery was 100.30 % and the linearity showed absence of curvature in the range of 80 to 120 %. The expanded uncertainty calculated was less than 2 % of the amounts in the samples. All validation parameters evaluated were within acceptation limits established, therefore it is concluded that the method is suitable for the intended purposes.
ABSTRACT
The main purpose of this study was to develop a novel, in situ gel system for sustained delivery of ranitidine hydrochloride. Ranitidine in situ gels at 0.2%, 0.5%, and 1.0% gellan gum concentration (w/v) were prepared, respectively, and characterized in terms of preparation, viscosity and in vitro release. The viscosity of the gellan gum formulations in solution increased with increasing concentrations of gellan gum. In vitro study showed that the release of ranitidine from these gels was characterized by an initial phase of high release (burst effect) and translated to the second phase of moderate release. Single photon emission computing tomography technique was used to evaluate the stomach residence time of gel containing 99mTc tracer. The animal experiment suggested in situ gel had feasibility of forming gels in stomach and sustained the ranitidine release from the gels over the period of at least 8 h. In conclusion, the in situ gel system is a promising approach for the oral delivery of ranitidine for the therapeutic effects improvement.
Subject(s)
Animal Experimentation , Gels , Gingiva , Ranitidine , Stomach , ViscosityABSTRACT
Simple, rapid and sensitive spectrophotometric procedure is suggested for the determination of ranitidine hydrochloride (RNH) drug in pure form and in pharmaceutical formulations. The method was based on the ionpair formations of RNH with different dyestuff reagents such as methyl orange (MO), bromocrysol purple (BCP), eriochrome cyanine R (ECR) and alizaraine red S (ARS). The obtained ion-pairs were measured spectrophotometrically at 408, 420, 330 and 326 nm by using BCP, MO, ECR and ARS reagents, respectively. Beer’s plots were linear in the concentration range of 5-200, 20-350, 10-150 and 10-180 μg mL−1 RNH, with correlation coefficients not less than 0.9991, 0.9996, 0.9993 and 0.999 using BCP, MO, ECR and ARS reagents, respectively. The Sandell sensitivity was found to be 0.813, 0.462, 0.541and 0.630 μg cm−2 for BCP, MO, ECR and ARS, respectively. Standard deviation (SD = 0.024-0.028, 0.018-0.023, 0.016-0.021 and 0.023–0.029) and relative standard deviation (RSD% = 0.123-0.943, 0.0102-0.82, 0.118-0.145 and 0.132-0.178%) (n = 4) values using BCP, MO, ECR and ARS reagents, respectively, were obtained. These results were also confirmed with percent recovery of 99.78–100.52%, 99.86-101.12%, 99.82–100.31% and 100.18-101.25 % for BCP, MO, ECR and ARS reagents, respectively. This method was successfully applied for determination of RNH in aciloc tablet. The calculated t- and F- values (95% confidence limit) indicate no significant differences between the proposed and official methods.