Abstract
A novel approach was carried out to develop and validate a rapid, specific, accurate and precise reverse phase ultra performance liquid chromatographic (UPLC) method for the simultaneous separation and quantification of secnidazole, fluconazole and azithromycin in pharmaceutical dosage forms. The developed analytical method is superior in technology to conventional HPLC with respect to time, resolution, solvent consumption and cost of analysis. Elution time for the separation was 10 min and ultra violet detection was carried out at 210 nm. Efficient separation was achieved on BEH C18 sub-2-μm UPLC column using 0.002 M Na2HPO4and acetonitrile as organic solvent in a gradient program. Benzophenone was used as internal standard. Resolutions between secnidazole, fluconazole and azithromycin were found to be more than 4.8. The calibration graphs were linear for secnidazole, fluconazole, benzophenone and azithromycin. The method showed excellent recoveries for all dosage forms. The test solution was found to be stable in diluent for 72 h when stored in the refrigerator between 2 to 8°C. The proposed UPLC method was validated with respect to linearity, accuracy, precision, specificity and robustness and can be used for the simultaneous estimation of secnidazole, fluconazole and azithromycin in tablet dosage forms available as a combi kit.
Highlights
Ultra performance liquid chromatography (UPLC) is an innovative product that brought revolution in high performance liquid chromatography by outperforming conventional HPLC
To the best of our knowledge, a validated reverse phase UPLC method for the simultaneous separation and estimation of secnidazole, fluconazole and azithromycin disclosed in this investigation was not published elsewhere which is described in this investigation
The proposed reverse phase UPLC method has the advantage of simultaneous estimation of these three drugs in a short span of 10 min run time and the method was applied to dosage forms successfully
Summary
Ultra performance liquid chromatography (UPLC) is an innovative product that brought revolution in high performance liquid chromatography by outperforming conventional HPLC. To the best of our knowledge, a validated reverse phase UPLC method for the simultaneous separation and estimation of secnidazole, fluconazole and azithromycin disclosed in this investigation was not published elsewhere which is described in this investigation. AZTM does not interact with the hepatic cytochrome P450 system and is not associated with the pharmacokinetic drug interactions seen with erythromycin and other macrolides[11] It is available as a tablet and usually dosed 1 h before or 2 h after meal. The proposed reverse phase UPLC method has the advantage of simultaneous estimation of these three drugs in a short span of 10 min run time and the method was applied to dosage forms successfully. Twenty tablets each containing 150 mg of fluconazole (FCZ), 1000 mg of secnidazole (SNZ) and 1000 mg of azithromycin (AZTM) were weighed individually to determine the average tablet weight and powdered in a mortar. The amount of fluconazole, secnidazole and azithromycin per tablet was found
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