DEVELOPMENT OF RAMIPRIL REFERENCE MATERIAL AND ITS IMPURITIES SEPARATION

• Main Author: Widhiyanti, Kurnia
• Format: Theses
• Language: Indonesia
• Online Access: https://digilib.itb.ac.id/gdl/view/78958
• Institution: Institut Teknologi Bandung

Reference materials are very important for quality assurance of pharmaceuticals and widely applied for a lot of analytical measurements. Despite its important role, the availability of many reference materials in Indonesia are very limited. The aim of this research was to obtain candidate of ramipril reference material from ramipril pharmaceutical grade. This material was tested for its identity, purity and subsequently assayed to determine its assigned value. Infrared and Nuclear Magnetic Resonance spectrometric measurements confirmed the identity of ramipril. Results of organic and inorganic impurities, watér contents, loss on drying determination and Differential Scanning« Calorimetry measurement revealed that the compound was highly pure. Applying mass balance principle, the quantitative purity of ramipril was assigned to be 99.46% ± 0.01%. In addition, titrimetric and High Performance Liquid Chromatography (HPLC) determinations applying ramipril from United States of Pharmacopoeia Reference Standard (USPRS) gave the quantitative purities of 100.98 ± 0.18% and 100.13 ± 0.09% respectively. After 40 days storage of ramipril in an oven at 50 oc, the HPLC assay result is 98.47%. The collaborative HPLC determination results of three laboratories revealed that the quantitative purity of ramipril was 100.05 ± 0.10%. Based on overall results, it was concluded that the candidate of ramipril reference material from ramipril pharmaceutical grade was successfully obtained. This candidate was ready to be certified by authorized body, after which the ramipril reference material can be applied for analytic?d •purposes in testing laboratories comply with ISO/IEC 17025:2005.