A novel collagenase-assisted extraction of active pharmaceutical ingredients from gelatin products for quantitative analysis by high performance liquid chromatography.
High performance liquid chromatography (HPLC) is frequently used for quantifying drugs in gelatin capsules. Gelatin has a strong UV absorption that often overlaps with drug absorbances. Therefore, the gelatin capsules must be removed manually before analysis. This study describes a novel extraction method named collagenase-assisted extraction (CAE), which uses collagenase to degrade gelatin into fragments with reduced hydrophobicity, allowing gelatin-related peaks to elute immediately, eliminating interference with the drug peak and enabling use of whole gelatin capsules during drug quantification. Use of CAE eliminates powder loss when opening a gelatin capsule, allows extraction of drugs from the capsule, reduces analytical time, and extends HPLC column life.
Analytical Chemistry, PreClinical Development, Banyu Pharmaceutical Co., Ltd., 3 Okubo, Tsukuba, Ibaraki 300-2611, Japan.
Chenhua
C
Zhao
Shuntaro
S
Furukawa
Yasuhiro
Y
Ohki
D002214:Capsules / Q000737:chemistry*; D002851:Chromatography, High Pressure Liquid / Q000379:methods*; D017364:Collagenases / Q000378:metabolism*; D005656:Fungal Proteins / Q000378:metabolism*; D005780:Gelatin / Q000737:chemistry*; D004364:Pharmaceutical Preparations / Q000032:analysis; D013302:Streptomyces / Q000201:enzymology
D002214:Capsules; D005656:Fungal Proteins; D004364:Pharmaceutical Preparations; D005780:Gelatin; D017364:Collagenases