我在网上看这样一段话FDA defines stability-indicating assay as an analytical method that accurately ...
Stability indicating assay method for estimation of Olmesartan Medoxomil and its metabolite. J. Liq. Chromatogr. & Rel. Technol. 2009, 32, 1516-1526.Trivedi P. Kartikeyan C. Kachave R. Bhadane R., Stability-Indicating Assay Method for Estimation of Olmesartan Medoxomil and its metabolite, J....
The FDA recommends that all assay procedures or stability should be stability indicating. There are basically 3 steps necessary or developing a SIM: 1) generation o degraded samples or testing selec- tivity o the method, 2) method development (manipulating and evaluating selectivity/ speci icity) ...
Stability indicating method development and validation of assay method for the estimation of rizatriptan benzoate in tabletRizatriptanRizatriptan benzoateMethod developmentValidationForced degradationA simple, sensitive, precise and specific high performance liquid chromatography method was developed and ...
Stability indicating HPLC assay method for the standard drug cefoperazone was developed using reverse phase appurassil C-18, 250 X 4.6mm. 5碌m column, in the mobile phase phosphate buffer (pH 6.8) and methanol (5:2) at flow rate 1mLmin-1 with UV detection at 254 nm. The retention ...
Raj, K.D., Ravi, R., Subburaju, T., Revathi, H., Arul, C., Ganapathirao, N.; Development and validation of stability-indicating RP-HPLC assay method for entacapone in entacapone tablets; International Journal of Pharmaceutical Sciences and Research, (2013); 4: 1227-1232....
The degradation products produced as a result of this stress did not interfere with the detection of diacerein, and the assay could thus be regarded as stability-indicating. The method was suitable for application in the analysis of formulations of diacerein in quality-control laboratories, because ...
Singh, Study of forced degradation behavior of enalapril maleate by LC and LC-MS and development of a validated stability-indicating assay method, J. ... SP Bhardwaj,S Singh - 《Journal of Pharmaceutical & Biomedical Analysis》 被引量: 102发表: 2008年 Stress Degradation Studies on Varenicline ...
The objective of the present work was to development and validation of stability indicating RP-HPLC assay by applying different stress degradation conditions on lornoxicam in Self Emulsifying Drug Delivery System (SEDDS) formulation. HPLC separation was achieved on analytical technique using C-18 column...
A validated specific stability indicating reversed-phase high-performance liquid chromatography method was developed for the quantitative determination of Amsacrine as well as its related substances determination in bulk samples, in presence of degradation products, and its process related impurities. Forced ...