Abstract:
A method based on single column ion chromatography with UV detection was developed for purity testing and assay of monosodium olpadronate. The analyte aqueous solution is precipitated with methanol to enhance the impurities/olpadronate molar ratio, thus improving purity determination at trace levels. The resulting solution is injected into a standard chromatographic system with UV detector in indirect mode with a Waters IC Pak HR column using diluted nitric acid as the mobile phase. The method was fully validated according to ICH guidelines for the determination of phosphite, phosphate, chloride and methanesulfonic acid in olpadronate being suitable for purity testing and assay. © 2001 Elsevier Science B.V.
Registro:
Documento: |
Artículo
|
Título: | Ion exchange chromatographic determination of olpadronate, phosphate, phosphite, chloride and methanesulfonic acid |
Autor: | Quattrocchi, O.; Frisardi, L.; Iglesias, M.; Noya, M.; Caputto, M.; Ferraris, D.; Siliprandi, D.; Piccinni, E. |
Filiación: | Analytical Development Department, Gador S.A., Cramer 2462, 1428 Buenos Aires, Argentina
|
Palabras clave: | Bisphosphonate analysis; HPLC; Impurities; Ion chromatography; Olpadronate; chloride; mesylic acid; nitric acid; olpadronic acid; phosphate; phosphite; accuracy; conference paper; drug formulation; drug impurity; drug purity; ion exchange chromatography; priority journal; Chlorides; Chromatography, Ion Exchange; Diphosphonates; Mesylates; Phosphates; Phosphites; Sensitivity and Specificity; Spectrophotometry, Ultraviolet |
Año: | 2001
|
Volumen: | 24
|
Número: | 5-6
|
Página de inicio: | 1011
|
Página de fin: | 1018
|
DOI: |
http://dx.doi.org/10.1016/S0731-7085(00)00535-5 |
Título revista: | Journal of Pharmaceutical and Biomedical Analysis
|
Título revista abreviado: | J. Pharm. Biomed. Anal.
|
ISSN: | 07317085
|
CODEN: | JPBAD
|
CAS: | Chlorides; Diphosphonates; Mesylates; methanesulfonic acid, 75-75-2; olpadronic acid, 63132-39-8; Phosphates; Phosphites
|
Registro: | https://bibliotecadigital.exactas.uba.ar/collection/paper/document/paper_07317085_v24_n5-6_p1011_Quattrocchi |
Referencias:
- Chester, T., Lewis, E., Benedict, J., Sunberg, R., Tettenhorst, W., (1981) J. Chromatogr., 225, pp. 17-25
- Tsai, E., Singh, M., Lu, H., Ip, D., Brooks, M., (1992) J. Chromatogr., 626, pp. 245-250
- Zeller, M., Kessler, R., Manz, H., Szekely, G., (1991) J. Chromatogr., 545, pp. 421-425
- Daley-Yates, P., Gifford, L., Hoggarth, C., (1989) J. Chromatogr., 490, pp. 329-338
- Kline, W., Matuszewski, B., Bayne, W., (1990) J. Chromatogr., 534, pp. 139-149
- Kline, W., Matuszewski, B., (1992) J. Chromatogr., 583, pp. 183-193
- King, R., Vieth, (1996) J. Chromatogr. B, 678, pp. 325-330
- Kwong, W., Chiu, A., McClintock, S., Cotton, M., (1990) J. Chromatogr. Sci., 28, pp. 563-566
- Kosonen, J., (1992) J. Pharm. Biomed. Anal., 190, pp. 881-887
- Huber, J., Calabrese, K., (1985) J. Liq. Chromatogr., 8, pp. 1989-2001
- De Marco, J., Biffar, S., Reed, D., Brooks, M., (1989) J. Pharm. Biomed. Anal., 7, pp. 1719-1727
- Sparidans, R., Den Hartigh, J., Beijnen, J., Vermeij, P., (1997) J. Chromatogr. B, 696, pp. 137-144
- Ostovic, D., Stelmach, C., Hulshizer, B., (1993) Pharm. Res., 10, pp. 470-472
- Sparidans, R., Den Hartigh, J., Verjeij, P., (1995) J. Pharm. Biomed. Anal., 13, pp. 1545-1550
- Quitasol, J., Krastins, L., (1994) J. Chromatogr. A, 671, pp. 273-279
- (1999) British Pharmacopoeia, 1, pp. 536-537. , Department of Health, London
- Tsai, E., Ip, D., Brooks, M., (1992) J. Chromatogr., 596, pp. 217-224
- Den Hartigh, J., Langebroek, R., Vermeij, P., (1993) J. Pharm. Biomed. Anal., 11, pp. 977-983
- Tsai, E., Chamberlain, S., Forsyth, R., Bell, C., Ip, D., Brooks, M., (1994) J. Pharm. Biomed. Anal., 12, pp. 983-991
Citas:
---------- APA ----------
Quattrocchi, O., Frisardi, L., Iglesias, M., Noya, M., Caputto, M., Ferraris, D., Siliprandi, D.,..., Piccinni, E.
(2001)
. Ion exchange chromatographic determination of olpadronate, phosphate, phosphite, chloride and methanesulfonic acid. Journal of Pharmaceutical and Biomedical Analysis, 24(5-6), 1011-1018.
http://dx.doi.org/10.1016/S0731-7085(00)00535-5---------- CHICAGO ----------
Quattrocchi, O., Frisardi, L., Iglesias, M., Noya, M., Caputto, M., Ferraris, D., et al.
"Ion exchange chromatographic determination of olpadronate, phosphate, phosphite, chloride and methanesulfonic acid"
. Journal of Pharmaceutical and Biomedical Analysis 24, no. 5-6
(2001) : 1011-1018.
http://dx.doi.org/10.1016/S0731-7085(00)00535-5---------- MLA ----------
Quattrocchi, O., Frisardi, L., Iglesias, M., Noya, M., Caputto, M., Ferraris, D., et al.
"Ion exchange chromatographic determination of olpadronate, phosphate, phosphite, chloride and methanesulfonic acid"
. Journal of Pharmaceutical and Biomedical Analysis, vol. 24, no. 5-6, 2001, pp. 1011-1018.
http://dx.doi.org/10.1016/S0731-7085(00)00535-5---------- VANCOUVER ----------
Quattrocchi, O., Frisardi, L., Iglesias, M., Noya, M., Caputto, M., Ferraris, D., et al. Ion exchange chromatographic determination of olpadronate, phosphate, phosphite, chloride and methanesulfonic acid. J. Pharm. Biomed. Anal. 2001;24(5-6):1011-1018.
http://dx.doi.org/10.1016/S0731-7085(00)00535-5