Abstract
Objective: The objective of the study was to develop and validate a new rapid and sensitive reverse phase ultra-performance liquid chromatographic (RP-UPLC) method for determination of cefdinir in bulk drug and dosage form.Methods: Separation was achieved with an Acquity SB C18 (100 × 2 mm) 1.8μm column with an isocratic mobile phase containing a mixture of orthophosphoric acid and acetonitrile (60:40 v/v) and pH adjusted to 2.8. The flow rate of the mobile phase was 0.3 ml/min with a column temperature of 30 °C and detection wavelength at 285 nm.Results: The method was validated with respect to linearity, accuracy, precision, detection limits, robustness and specificity. The precision of the results, stated as the relative standard deviation was below 1.5%. The calibration curve was linear over a concentration range from 25 to 150μg/ml with a correlation coefficient of 0.9993. The accuracy of the method demonstrated at three levels in the range of 50%, 100% and 150% of the specification limit. The recovery of cefdinir was found to be in the range of 98 to 102%, whereas the detection limits were found to be 0.17 and 0.51µg/ml. Forced degradation study was carried out under acidic, alkaline, oxidative, photolytic and thermal conditions to prove the stability-indicating ability of the developed UPLC method.Conclusion: The developed method was validated with respect to linearity, accuracy, precision limit of detection and quantification, robustness and specificity. The method was applied successfully for the determination of cefdinir in tablets.
Highlights
Pharmaceutical analysis by definition deals with the analysis of drugs, pharmaceutical substances and raw materials
The international conference on harmonisation (ICH) guidelines attained a great deal in harmonizing the definitions of the impurities in new drug substances [1]
High-performance liquid chromatography (HPLC) is a well-known technique used in controlling the quality and consistency of active pharmaceutical ingredients (APIs) and dosage forms
Summary
Pharmaceutical analysis by definition deals with the analysis of drugs, pharmaceutical substances and raw materials. As HPLC methods have been commonly used for routine quality control assessment of drugs, because of its sensitivity, repeatability and specificity. HPLC is a well-known technique used in controlling the quality and consistency of active pharmaceutical ingredients (APIs) and dosage forms. It is often a slow technique because of the complexity of some of the samples and it could still be enhanced. A novel category of separation technique, ultraperformance liquid chromate-graphy (UPLC), has proven to be one of the most promising developments in the area of fast chromatographic separations with its unique characteristics of high chromatographic resolution, speed and sensitivity analysis [4]. UPLC system reduces considerable time and cost per sample from the analytical process while improving the quality of results, the system allows chromatographers to work at higher efficiencies, flow rates and back pressures [6]
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