Stability study of ciprofloxacin hydrochloride under stress conditions using reverse phase -high performance liquid chromatography method

The present study describes behavior of ciprofloxacin hydrochloride (Cipro-HCl) which was investigated under different stress conditions of sun light, UV light at 254 nm and some pharmaceutical excipients using HPLC. RPHPLC method were modified that could separate the drug from its degradation products formed under these stress conditions. Degradation was found to occur under sun light and thermal, were successfully resolved on a C18 column (5S, ODS 25 cm × 4.6 mm, 5μm), utilizing mobile phase of 0.025 M orthophospharic acid (adjusted to pH 3.0 with triethylamine) and acetonitrile in a ratio of 87:13 respectively. Mobile phase was delivered at the flow rate of 1.5 ml/min. Ultra violet detection was carried out at 278 nm. The method was validated with respect to linearity, precision, accuracy, selectivity, specificity and ruggedness. The method was specific to drug and also selective to degradation products. Some pharmaceutical excipinents were found to decrease the reaction rate of sunlight and thermal decomposition of ciprofloxacin hydrochloride in aqueous media. Other pharmaceutical excipinents were found to increase the reaction rate of ciprofloxacin hydrochloride sun and thermal decomposition.

Author(s): Elsadig H. K. Adam, Mohammed E Mukhtar, Abd Elaziz and Ahmed E. M. Saeed

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