Development and validation of a method for active drug identification and content determination of ranitidine in pharmaceutical products using near-infrared reflectance spectroscopy: a parametric release approach.

In this paper we describe the strategy used in the development and validation of a near-infrared diffuse reflectance spectroscopy method for identification and quantification of ranitidine in pharmaceutical products (granulates, cores and coated tablets) at-line, with a fiber optic probe. This method was developed in a pharmaceutical industry for routine application, to replace reference methods and was submitted and approved to the National Medicine Regulatory Agency (Infarmed). We consider that this is the first step of a broader parametric release approach to pharmaceutical products.