DEVELOPMENT OF COMPARATIVE DISSOLUTION METHOD AS QUALITY WARRANTY AND COMPLIANCE OF REGULATION: CASE STUDY ON SOME ACTIVE PHARMACEUTICAL INGREDIENTS

• Main Author: Angelia, Inez
• Format: Theses
• Language: Indonesia
• Online Access: https://digilib.itb.ac.id/gdl/view/44462
• Institution: Institut Teknologi Bandung

The issuance of the Indonesia Regulation of the Head of the Drug and Food Control Agency on the rules of equivalence test, trigger the pharmaceutical industry to begin evaluating its products. One approach that is done is to test the dissolution of comparable. The development of comparative dissolution methods conducted in this case study involves the development of dissolved dissolution test conditions, the dissolution medium and the development of analytical methods for drugs proven to have problems for either of these two problems. The development of the test conditions undertaken was to develop a dissolution medium for preparation with an active substance with low solubility in water such as fenofibrate and allyestrenol. The development of the dissolution medium carried out in the dissolution of fenofibrate and allyestrenol is by the addition of SLS into the dissolution medium. The development of the analytical method consists of two aspects, namely the development of the analytical method used (for the case of interference from excipients, the dry suspension cefadroxil case) and the test solution preparation method (for the case of unstability test solution), for Levodopa / Benserazide tablets and capsules Omeprazole). In the case of cefadroxil, a method of assaying has been developed using the HPLC method. The development of test preparation preparation method for the levodopa / benserazide tablet case was carried out by diluting the test solution using a solvent which increased the stability of the test solution such as the mobile phase. For the case of the omeprazole capsule, a method to improve the stability of the test solution is to store the test solution at a low temperature.