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Spectrophotometric and Stability-Indicating High-Performance Liquid Chromatographic Determinations of Terbutaline Sulfate
Faculty
Pharmacy
Year:
2012
Type of Publication:
Article
Pages:
1412-1417
Authors:
Elmasry, Manal S, Jira, Thomas, Hashem, Hisham A, Hassan, Wafaa E, Truendelberg, Clemens
DOI:
10.5740/jaoacint.11-056
Journal:
JOURNAL OF AOAC INTERNATIONAL AOAC INT
Volume:
95
Research Area:
Chemistry; Food Science \& Technology
ISSN
ISI:000310652300020
Keywords :
Spectrophotometric , Stability-Indicating High-Performance Liquid Chromatographic Determinations
Abstract:
Spectrophotometric and stability-indicating HPLC procedures are described for determination of terbutaline sulfate in bulk powder and dosage form. The first procedure is based on diazo coupling of the phenolic groups of terbutaline sulfate with fast red B salt in the presence of sodium hydroxide. The colored compound developed in alkaline medium was measured at 475 nm. Different variables affecting the reaction were studied. Beer's Law is obeyed in the concentration range of 1-6 mu g/mL. In the HPLC procedure, the separation was carried out on a Caltrex (R) AIII column, a relatively new packing material consisting of silica-bonded calix({[}8])arene, using an isocratic binary mobile phase, acetonitrile ammonium acetate (50+50, v/v), at pH 6.2. A diode array detector was used at 280 nm. The method was validated for system suitability, linearity, precision, LOD, LOQ, specificity, stability, and robustness. The LOD and LOQ were 0.196 and 0.781 mu g/mL, respectively. The recovery values of this method were between 98 and 102\%, and the reproducibility was within 0.92\%. Statistical comparison of the results obtained from the analysis of the studied drug to those of the official British Pharmacopoeia (2007) method using t- and F-tests showed no significant difference between them.
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