(T1130-09-60) A Study on the Modernization of Analytical Methods in Korean Pharmacopoeia

Purpose: Korean Pharmacopoeia(KP) is a basic national standard for pharmaceutical quality management established by the Ministry of Food and Drug Safety(MFDS) to promote public health. KP is widely used from pharmaceutical development to quality control, so efficient and sustainable revisions are needed to strengthen field utilization. MFDS has been making efforts to improve the KP that reflects new technologies and global harmonization, but there are still old-fashioned analytical methods. In order to modernize the test method in monographs, MFDS studied on the change of packed column to capillary column of GC analytical methods, and replace the titration using hazardous reagents and TLC for related compounds test with the chromatography such as HPLC.

Methods: Packed columns are difficult to obtain on the market and have disadvantage of utilization due to relatively low accuracy than capillary columns. For this reasons, demands to revise of the test methods have been continuously raised from pharmaceutical manufacturers. In this study, the verification of 5 analytical methods between 63 GC packed column test methods in KP monographs were investigated. Furthermore, mercury acetate TS, which is widely used in the potentiometric titration methods, is classified as a hazardous reagent and is difficult to use and dispose of, so it has been improved to an alternative analysis methods. In the case of trace analysis methods such as related compounds tests, it has been changed to chromatography with high specificity because it was difficult to sufficiently confirm with TLC. These items were determined to reflect domestic approved drug products and manufacturer’s request for revision.

Results: As a result, the specificity(absence of interference), accuracy(average recovery 96.3-101.3%, limit of range 95-105%) and precision(RSD 0.2-2.5%, limit of RSD ≤ 5.0%) were acceptable with the guideline of validation of analytical procedures in KP.

Conclusion: In conclusion, these methods can be used as an alternative analytical methods to replace old-fashioned test methods.

References: 1. The United States Pharmacopoeial Convention, The United States Pharmacopoeia, USP-NF
2. EDQM Council of Europe, European Pharmacopoeia 10.8

HPLC chromatogram for specificity of pentoxifylline

HPLC chromatogram for specificity of sodium valproate

GC chromatogram for specificity of hypromellose acetate succinate