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Forced‐degradation study of valdecoxib as bulk drug and in tablet formulation by HPTLC
Author(s) -
Ravi Thengungal Kochupappy,
Gandhimathi Muruganathan,
Suganthi Azhewar,
Sarovar Sabitha
Publication year - 2006
Publication title -
journal of separation science
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.72
H-Index - 102
eISSN - 1615-9314
pISSN - 1615-9306
DOI - 10.1002/jssc.200600028
Subject(s) - valdecoxib , repeatability , chromatography , forced degradation , degradation (telecommunications) , chemistry , calibration curve , engineering , detection limit , electronic engineering , rofecoxib , cyclooxygenase , enzyme , biochemistry
A stability‐indicating forced‐degradation study of valdecoxib was conducted using high performance thin layer chromatography (HPTLC). It was used to analyze valdecoxib as bulk drug and as tablets. Undegraded valdecoxib was eluted with a retardation factor, R f , of 0.56. Valdecoxib was forcibly degraded by exposure to alkali, acid, oxidation, and light, the greatest degradation occurring under basic conditions. Base‐degraded valdecoxib gave an additional peak with an R f value of 0.76. The calibration curve was linear in the range of 0.2–1 μg/μL with a correlation coefficient of 0.9952. Complete validation was carried out for precision (inter‐day, intra‐day, repeatability), accuracy, and robustness. All the data were analyzed statistically. This HPTLC procedure shows the reliability needed for use as a stability‐indicating method. It can quantify valdecoxib in bulk and in tablets and also resolves the degraded peak of valdecoxib. This method is also useful for studying the degradation pattern and degradation mechanism of valdecoxib.