scholarly journals Validated stability indicating liquid chromatographic determination of ebastine in pharmaceuticals after pre column derivatization: Application to tablets and content uniformity testing

2011 ◽  
Vol 5 (1) ◽  
Author(s):  
Fawzia Ibrahim ◽  
Mohie Khaled Sharaf El- Din ◽  
Manal Ibrahim Eid ◽  
Mary Elias Kamel Wahba
1987 ◽  
Vol 70 (5) ◽  
pp. 834-836
Author(s):  
Ella S Moore

Abstract A liquid chromatographic method for the determination of coumarin anticoagulants in tablets was collaboratively studied by 7 laboratories. The method uses an octadecylsilane-bonded microparticulate column, tetrahydrofuran-methanol-water-acetic acid mobile phase, and photometric detection at 311 nm. Each collaborator received samples of warfarin sodium, phenprocoumon, and dicumarol as a synthetic composite and as commercial individual and composited tablets. Pooled average assay values for synthetic and commercial tablet samples of warfarin sodium were 101.6 and 99.5%, respectively, with a combined reproducibility SD of 2.38% (CV = 2.37%) and combined repeatability SD of 1.49% (CV = 1.49%). Pooled average (SD) assay values for dicumarol and phenprocoumon commercial samples were 98.0 (2.27) and 101.3% (4.00), respectively. The content uniformity determinations of 2 mg warfarin sodium and 25 mg dicumarol tablets indicated average tablet contents (range) of 99.5% (91.0-116.0) and 98.0% (89.8-108.8), respectively. The method has been approved interim official first action


1985 ◽  
Vol 68 (3) ◽  
pp. 529-532
Author(s):  
Leonard P Valenti ◽  
Cesar A Lau-Cam

Abstract A method is described for the determination of bisacodyl in entericcoated tablets and suppositories by liquid chromatography (LC). The method will also determine the hydrolysis degradation products monoacetylbisacodyl and desacetylbisacodyl. The sample is dissolved in 2- propanol, and the extract is diluted with the mobile phase and injected into a liquid chromatograph fitted with a μBondapak C18 column and an ultraviolet detector set at 254 nm. The column is eluted with methanol- acetonitrile-0.01M citric acid (25 + 25 + 50). The pooled mean recovery value for bisacodyl from commercial enteric-coated tablets and suppositories was 99.7 % with a pooled coefficient of variation (CV) of 0.72%. For content uniformity assays, the CVs were 0.7 and 1.0% for groups of 10 individual commercial suppositories and tablets, respectively. Differences between assay values by the LC and USP XX methods were 0.2% of declared for enteric-coated tablets (n = 5) and 1.0% of declared for suppositories (n = 2). The LC method can determine as little as 0.015 μg of the monoacetyl or desacetyl degradation product.


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