A Study On Process Reform Of Bulk Ranitidine Hydrochloride

It is indicated in the paper that the reformed process of Ranitidine Hydrochloride is set up by the research of the current production procedure, through a series of experiments of simulating the actually process and the theoretic design, for the aim of increasing the transmittance and acceptable batches of the product. From the study of the current process and parameter, the factor which leading to the unstable of the specification is founded and the process reform base is supplied by the research experiment.For the first step, a series of absorption test is carried by using the activated carbon, Na filtration and iron resin for deduce the related substance in the ranitidine base, but the result is no deduce of the purities.After reform, the low transmittance and instability were well resolved, and the average value of transmittance of the product has increased 5%, the quality can comply with the international standard.Meanwhile, A new analysis method of Ranitidine base is set up for quality control of the starting material, and a method validation is carried out according to the ICH Q2A, The validation result is that the method is well linearity when the test solution concentration is 16.29μg/ml～260.72μg/ml, the curve equation is y=48.03x+47.862, the related coefficient was r=1 (n=5) , the method can be used for quality control of ranitidine with accuracy and reproducibility and can be a base for a total quality control of the production.