| Summary: | Currently, the admixture of ciprofloxacin hydrochloride (Sip.HCl) and
metronidazole (Mdz) is used as a combined therapy for the treatment of infections
caused by either aerobic and anaerobic bacteria. The aim of this study was to develop
and to validate a new HPLC method capable of facilitating for determination of both
drugs in tablet dosage forms.
The method was based on the liquid chromatographic separation of Sip.HCl
and Mdz by addition of triethylamine as an ion pair reagent to reduce tailing for
Sip.HCl. Drugs were separated on reversed phase Lichrospher 100 RP-18 C18 column
(100 mm x 4.6 mm ID, 5 μm). The mobile phase consisted of monobasic potassium
phosphate (50 mM, pH 3.5) and acetonitrile (80: 20, v/v) containing triethylamine
(7.5 mM). Mobile phase was delivered isocratically at flow rate of 1.0 mL/min. UV
detection was set at 298 nm.
The developed method was validated in terms of precision, accuracy,
linearity, selectivity and sensitivity. The proposed method complied with the validity
requirements. The precision of the method was evaluated using repeatability assay
having RSD values of 0.37 � 1.72% for Sip.HCl and 0.10 � 1,90% for Mdz.
Accuracy, expressed as recovery percentage using standard addition method showed
mean recoveries of 99.83 � 100.77% (Sip.HCl) and 100.01 � 101.15% (Mdz). This
method provided linear responses (r > 0,99) within the concentration range of 30 � 90
µg/mL for the both drugs. LOQ for Sip.HCl and Mdz were 29.47 µg/mL and 8.84
µg/mL, respectively. This validated method has been successfully applied for the
analysis of binary mixture of Sip.HCl and Mdz in tablets.
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