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.
Rosa
Sílvia S
SS
Laboratórios Atral SA, Rua da Estação 42, Vala do Carregado, P 2600 726 Castanheira do Ribatejo, Portugal. silviarosa@ist.utl.pt
Barata
Pedro A
PA
Martins
José M
JM
Menezes
José C
JC
D000897:Anti-Ulcer Agents / Q000032:analysis; D006635:Histamine H2 Antagonists / Q000032:analysis; D011899:Ranitidine / Q000032:analysis*; D015203:Reproducibility of Results; D019265:Spectroscopy, Near-Infrared; D013607:Tablets
D000897:Anti-Ulcer Agents; D006635:Histamine H2 Antagonists; D013607:Tablets; D011899:Ranitidine