STABILITY-INDICATING HPLC METHODS FOR DRUG ANALISYS, edited by Quanyun A. Xu

STABILITY-INDICATING HPLC METHODS FOR DRUG ANALISYS

edited by Quanyun A. Xu

Editorial: Pharmaceutical Press & American Pharmacists Association (APha)

Páginas: 912

Año: 2008

Edición: 3era Edición

Presentación: Encuadernado

País de Procedencia: Inglaterra

Publicación Técnica y Científica para los profesionales en el campo de la ciencia farmacéutica en general. los analistas que participan en la evaluación de la estabilidad del fármaco, departamento de desarrollo, Control de Calidad, Regulación de Medicamentos, Académicos y profesionales relacionados al sector farmacéutico.

Stability-Indicating HPLC Methods for Drug Analysis, third edition, is structured a series of monographs on 572 different drug entities, including 96 new in this edition. These monographs have been prepared from 851 published references and present 1,028 stability-indicating HPLC analytical methods. The information that is presented in the monographs has been gathered from the published literature and is summarized in a structured textual format composed of 30 elements.

In depth description of the HPLC analysis presented in original publication.

Components

The first series of monograph elements were obtained from standard reference works. This information in the basic information analyst may find useful in analyzing various drug products. The information presented includes:

1. Chemical name (s)

2. Molecular structure

3. Other name (s)

4. Form (s) of the drug molecule available in drug products

5. Molecular formula

6. Molecular weight

7. CAS number

8. Appearance and description

9. solubility’s

10. pKa values

The Basic information in followed by one or more summaries of previously published stability – indicating analytical, methods. The summaries follow a highly structured ext format. Each of the informational items that follow is included when presented in the original published articles.

The reader should recognize that all too often one or more pieces of information were omitted in the original work and, consequently, do not appear in this compilation. However, the summaries have been made as complete as possible from the original published articles.

The first section of the method summary includes the following information:

11. Individual (s) who developed or published the method

12. Drug, salt form (if applicable), and presentation that was analyzed

13. Description of analytical system components

14. Description of column

15. Mobile phase composition and flow rate

16. Detection wavelength and sensitivity

17. Internal standard (if present)

The second section of the method includes:

18. Standard solution preparation

19. Sample preparation (dilution, extraction, derivatization, etc.)

20. Injection volume

21. Retention times for subject drug, secondary drug (s), and internal standard

The third section of the summary describes the demonstration of the Stability indicating nature of the method. The description includes:

22. The decomposition techniques and/or sample spiking that was used

23. Absence of interference of decomposition product with intact drug

24. Retention times for intact drug and degradation product.

The fourth section of the method summary includes the following Information:

25. Concentration range of the standard curve

26. Correlation coefficient and linearity

27. Coefficient of variation of the assay

28. Intraday and intraday coefficients of variation of the samples

29. Limit of detection and limit of quantitation.

And lastly, the source of the method is presented:

30. Reference (s)

The reference (s) form the published literature that utilized the particular method provides proper attribution and allows readers to more easily refer to the original work if that would be useful.

It has always seemed to us that the best starting point in identifying a suitable stability-indicating analytical method is from methods that have previously been shown to be stability indicating in studies by other researchers. Of course, finding an analytical method in the literature that has been found to be stability indicating in a previous study does not preclude the need to evaluate the methods in the analyst’s hands. The analyst is still obligated to assure the adequacy of the methods for specificity, precision, reproducibility, and sensitivity. Furthermore, the methods must be shown to separate and quantify the intact drug in the presence of its decomposition products and other dosage form components. However, this task of finding a suitable methods and documenting that it is both stability indicating and is functioning properly in one’s own laboratory is aided when the analyst start with a methods that has been shown by other to be stability indicating.

Analysis must also be aware that the presentation of a stability-indicating analytical method in the literature does not absolve them of the method in their own laboratory. The analysis still must determine fundamental performance parameters of the method including sensitivity, precision, reproducibility, and accuracy. Also, the stability-indicating ability of the analyst’s laboratory to demonstrate that the method is working properly. These are more likely to be easily achievable when the method has been shown to work in another analyst’s hands.