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Quantitation of Valdecoxib in human plasma by high-performance liquid chromatography with ultraviolet absorbance detection using liquid-liquid extraction.
J Chromatogr B Analyt Technol Biomed Life Sci. 2004 Apr 05; 802(2):271-5.JC

Abstract

A simple, sensitive and specific HPLC method with UV detection (210 nm) was developed and validated for quantitation of Valdecoxib in human plasma, the newest addition to the group of non-steroidal anti-inflammatory drugs-a highly selective cyclooxygenase-2 inhibitor. The analyte and an internal standard (Rofecoxib) were extracted with diethyl ether/dichloromethane (70/30 (v/v)). The chromatographic separation was performed on reverse phase ODS-AQ column with an isocratic mobile phase of water/methanol (47/53 (v/v)). The lower limit of quantitation was 10 ng/ml, with a relative standard deviation of <20%. A linear range of 10-500 ng/ml was established. This HPLC method was validated with between-batch and within-batch precision of 1.27-7.45 and 0.79-6.12%, respectively. The between-batch and within-batch bias was 0.74-7.40 and -0.93 to 7.70%, respectively. Frequently coadministered drugs did not interfere with the described methodology. Stability of Valdecoxib in plasma was excellent, with no evidence of degradation during sample processing (autosampler) and 30 days storage in a freezer. This validated method is suitable for bioequivalence studies following single dose in healthy volunteers.

Authors+Show Affiliations

Ramakrishna NV
Biopharmaceutical Research, Suven Life Sciences Ltd, Serene Chambers, Road # 7, Banjara Hills, Hyderabad 500034, India. nvsrk@suven.com
Vishwottam KN
No affiliation info available
Wishu S
No affiliation info available
Koteshwara M
No affiliation info available

MeSH

Chromatography, High Pressure LiquidCyclooxygenase InhibitorsHumansIsoxazolesReproducibility of ResultsSensitivity and SpecificitySpectrophotometry, UltravioletSulfonamides

Pub Type(s)

Journal Article

Language

eng

PubMed ID

15018787

Citation

Ramakrishna, N V S., et al. "Quantitation of Valdecoxib in Human Plasma By High-performance Liquid Chromatography With Ultraviolet Absorbance Detection Using Liquid-liquid Extraction." Journal of Chromatography. B, Analytical Technologies in the Biomedical and Life Sciences, vol. 802, no. 2, 2004, pp. 271-5.
Ramakrishna NV, Vishwottam KN, Wishu S, et al. Quantitation of Valdecoxib in human plasma by high-performance liquid chromatography with ultraviolet absorbance detection using liquid-liquid extraction. J Chromatogr B Analyt Technol Biomed Life Sci. 2004;802(2):271-5.
Ramakrishna, N. V., Vishwottam, K. N., Wishu, S., & Koteshwara, M. (2004). Quantitation of Valdecoxib in human plasma by high-performance liquid chromatography with ultraviolet absorbance detection using liquid-liquid extraction. Journal of Chromatography. B, Analytical Technologies in the Biomedical and Life Sciences, 802(2), 271-5.
Ramakrishna NV, et al. Quantitation of Valdecoxib in Human Plasma By High-performance Liquid Chromatography With Ultraviolet Absorbance Detection Using Liquid-liquid Extraction. J Chromatogr B Analyt Technol Biomed Life Sci. 2004 Apr 5;802(2):271-5. PubMed PMID: 15018787.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Quantitation of Valdecoxib in human plasma by high-performance liquid chromatography with ultraviolet absorbance detection using liquid-liquid extraction. AU - Ramakrishna,N V S, AU - Vishwottam,K N, AU - Wishu,S, AU - Koteshwara,M, PY - 2003/07/31/received PY - 2003/11/12/revised PY - 2003/11/25/accepted PY - 2004/3/17/pubmed PY - 2004/12/16/medline PY - 2004/3/17/entrez SP - 271 EP - 5 JF - Journal of chromatography. B, Analytical technologies in the biomedical and life sciences JO - J Chromatogr B Analyt Technol Biomed Life Sci VL - 802 IS - 2 N2 - A simple, sensitive and specific HPLC method with UV detection (210 nm) was developed and validated for quantitation of Valdecoxib in human plasma, the newest addition to the group of non-steroidal anti-inflammatory drugs-a highly selective cyclooxygenase-2 inhibitor. The analyte and an internal standard (Rofecoxib) were extracted with diethyl ether/dichloromethane (70/30 (v/v)). The chromatographic separation was performed on reverse phase ODS-AQ column with an isocratic mobile phase of water/methanol (47/53 (v/v)). The lower limit of quantitation was 10 ng/ml, with a relative standard deviation of <20%. A linear range of 10-500 ng/ml was established. This HPLC method was validated with between-batch and within-batch precision of 1.27-7.45 and 0.79-6.12%, respectively. The between-batch and within-batch bias was 0.74-7.40 and -0.93 to 7.70%, respectively. Frequently coadministered drugs did not interfere with the described methodology. Stability of Valdecoxib in plasma was excellent, with no evidence of degradation during sample processing (autosampler) and 30 days storage in a freezer. This validated method is suitable for bioequivalence studies following single dose in healthy volunteers. SN - 1570-0232 UR - https://www.unboundmedicine.com/medline/citation/15018787/Quantitation_of_Valdecoxib_in_human_plasma_by_high_performance_liquid_chromatography_with_ultraviolet_absorbance_detection_using_liquid_liquid_extraction_ DB - PRIME DP - Unbound Medicine ER -