Stability Indicating Reversed-Phase High Performance Liquid Chromatography Method for Determination of Impurities in Ofloxacin Tablet Formulations
- Stability Indicating Reversed-Phase High Performance Liquid Chromatography Method for Determination of Impurities in Ofloxacin Tablet Formulations
- 박정학; 프라빈쿠마르; B.V. Reddy[B.V. Reddy]; G.V. Ram Reddy[G.V. Ram Reddy]; M. Sahai[M. Sahai]; J. Sreeramulu[J. Sreeramulu]
- INJECTION; SEPARATION; URINE
- Issue Date
- TAYLOR & FRANCIS INC
- ANALYTICAL LETTERS, v.43, no.17, pp.2653 - 2662
- A gradient reversed-phase high performance liquid chromatography (RP-HPLC) method was developed for separation and quantitation of impurities in pharmaceutical dosage form of ofloxacin tablets. The developed method was a stability indicating test method for estimation of related impurities generated during synthesis, formulation, and storage of ofloxacin tablets. Forced degradation studies were performed on ofloxacin tablets including acid hydrolysis (5.0M hydrochloric acid), base hydrolysis (5.0M sodium hydroxide), oxidation (30% hydrogen peroxide), heat (105 degrees C) humidity degradation 25 degrees C/92% RH/119b 40min, and photolytic degradation (2600 Lux/119h 40min). From the degradation study, the degradation was found between 0-15%. Limit of detection and limit of quantification were established in terms of percentage for all potential impurities. The recovery studies were conducted on finished dosage samples (tablets) for all potential impurities and the average percentage recovery was ranged from 90.8 to 104.2. Placebo interference was verified by taking the placebo (composition of excipients) equivalent to weight in portion of test preparation and no interference was observed. The method was validated and found to be linear, accurate, precise, specific, robust, and reliable. The developed method was established in accordance to ICH guidelines.
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