Stability Indicating Methods for the Determination of Some Fluoroquinolones in the Presence of Their Decarboxylated Degradates
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概要
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Two stability-indicating methods, namely densitometric TLC and derivative spectrophotometry for the determination of the fluoroquinolone antibacterials lomefloxacin (Lfx), moxifloxacin (Mfx), and sparfloxacin (Sfx) in the presence of their acid degradates are described. Acid degradation was adopted and the main decarboxylated product separated by TLC. Degradation products were identified confirming a previously mentioned degradation scheme. The densitometric method is based on the separation of the intact drug from its acid degradation product on silica gel G plates using different mobile phases and the spots of the intact drugs were scanned at 288, 290, and 292nm for Lfx, Mfx, and Sfx, respectively. The derivative spectrophotometric method utilizes first derivative D_1 UV spectrophotometry with zero crossing points at 295.2nm for Lfx, 280.4 and 303.4nm for Mfx, and 280.8nm for Sfx. Regression analysis of Beer's plots showed good correlation in the concentration ranges 0.2-1.2, 0.1-1.4, and 0.5-2.0 μg/spot for Lfx, Mfx, and Sfx, respectively, in the densitometric method and 2-16 μg/ml for all drugs in the derivative spectrophotometric method. The proposed methods were successfully applied for the determination of the investigated drugs in bulk powder with mean percentage accuracy ranges from 98.93 to 101.25% for the TLC method and from 98.18 to 100.35% for the D_1 method. The proposed methods were also applied for the determination of the investigated drugs in their pharmaceutical dosage forms and their validity was assessed using the standard addition technique with mean percentage recovery ranging from 100.25 to 101.70% in the TLC method and from 99.27 to 102.12% in the D_1 method. The selectivity of the proposed methods was tested by the analysis of laboratory-prepared mixtures containing different percentages of the studied drugs and their acid degradates. The proposed methods were found selective for the determination of the intact drugs in the presence of up to 90% of their degradates in the TLC method and 70% for Lfx and 90% for Mfx and Sfx in the D_1 method.
- 公益社団法人日本薬学会の論文
- 2006-12-01
著者
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Abd-el-fattah Laila
Analytical Chemistry Department Faculty Of Pharmacy Cairo University
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Mikael Hanaa
National Organization For Drug Control And Research (nodcar)
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SALEM Maissa
Analytical Chemistry Department, Faculty of Pharmacy, Cairo University
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Salem Maissa
Analytical Chemistry Department Faculty Of Pharmacy Cairo University
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EL-GUINDI Nabawia
National Organization for Drug Control and Research (NODCAR)
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- Stability Indicating Methods for the Determination of Some Fluoroquinolones in the Presence of Their Decarboxylated Degradates