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Development and Validation of a Stability-Indicating HPLC Method for Determination of Ciprofloxacin Hydrochloride and its Related Compounds in Film-Coated Tablets

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Abstract

The objective of the current study was the development and subsequent validation of a simple, sensitive, precise and stability-indicating reversed-phase HPLC method for the determination of ciprofloxacin HCl in pharmaceutical dosage forms in the presence of its potential impurities. The chromatographic separation of ciprofloxacin HCl and its related compounds was achieved on an Inertsil ODS3 column using UV detection. The optimized mobile phase consisted of phosphoric acid solution: acetonitril. The proposed method provided linear responses within the concentration range 250–750 μg mL−1 for ciprofloxacin HCl and 0.5–1.5 μg mL−1 for its related compounds. LOD and LOQ values for the active substance were 5.159 and 15.632 μg mL−1, respectively. Correlation coefficients (r) of the regression equations for the impurities were greater than 0.99 in all cases. The precision of the method was demonstrated using intra- and inter-day assay RSD% values which were less than 1% in all instances. No interference from any components of pharmaceutical dosage forms or degradation products was observed.

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Acknowledgments

The authors greatly acknowledge Biofarma Pharmaceutical Industry Co. Inc., İstanbul, Turkey, for providing the gift samples of ciprofloxacin hydrochloride and its related compounds as well as Cipro® 500 mg film-coated tablet specimens and placebo powder mixture utilized throughout this study.

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Authors and Affiliations

  1. Biofarma Pharmaceutical Industry Co. Inc., Fatih Cad. No: 2, Kartal, 34885, Istanbul, Turkey

    B. Aksoy

  2. Department of Pharmaceutical Chemistry, Marmara University Faculty of Pharmacy, Haydarpasa, 34668, Istanbul, Turkey

    İ. Küçükgüzel & S. Rollas

Authors
  1. B. Aksoy
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  2. İ. Küçükgüzel
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  3. S. Rollas
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Correspondence to İ. Küçükgüzel.

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Application of Separation Techniques in Turkey

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Aksoy, B., Küçükgüzel, İ. & Rollas, S. Development and Validation of a Stability-Indicating HPLC Method for Determination of Ciprofloxacin Hydrochloride and its Related Compounds in Film-Coated Tablets. Chroma 66 (Suppl 1), 57–63 (2007). https://doi.org/10.1365/s10337-007-0287-6

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