Validation of Chromatographic Methods of Analysis: Application for Drugs That Derived From Herbs.
Profiles Drug Subst Excip Relat Methodol
; 43: 359-392, 2018.
Article
in En
| MEDLINE
| ID: mdl-29678264
ABSTRACT
It is well known that the quality control (QC) of drugs derived from herbs (DDHs) has two main problems first, DDHs are chemically complex mixtures, and second, the chemical contents of raw plant materials are affected by the site of cultivation, age of plants, methods of harvesting, and processing. QC is used by manufacturers to ensure the consistency, safety, and efficacy of the DDHs. QC of DDHs can be performed by two approaches, namely, marker-oriented and chemical pattern-oriented (metabolite profiling) using chromatographic methods. For having reliable results of any chemical analysis that will be performed in the QC laboratory, the method of analysis must be validated first before it can be routinely applied. Parameters of the validation method that should be evaluated for marker-oriented approach are stability, selectivity, linearity, trueness, precision, and robustness/ruggedness, while for metabolite profiling approach stability, intra- and interday precisions should be determined. Determination of instrumental and sample detection limit (DL), quantification limit (QL), and cutoff value is described in this review. Some relatively new validation methods that could correlate trueness and precision will be also discussed. The importance and application of metabolite profiling for a QC laboratory at pharmaceutical industry are discussed.
Key words
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
Chromatography
/
Technology, Pharmaceutical
/
Plant Preparations
/
Metabolomics
Language:
En
Journal:
Profiles Drug Subst Excip Relat Methodol
Year:
2018
Document type:
Article
Affiliation country:
Indonesia
Publication country:
HOLANDA
/
HOLLAND
/
NETHERLANDS
/
NL
/
PAISES BAJOS
/
THE NETHERLANDS