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ORIGINAL ARTICLE
Year : 2014  |  Volume : 5  |  Issue : 2  |  Page : 153-157

Reverse phase high-performance liquid chromatography method for the simultaneous estimation of sitagliptin with simvasatin in bulk and tablet formulation


Department of Pharmaceutical Chemistry, Government College of Pharmacy, Bengaluru, Karnataka, India

Correspondence Address:
G Manikanta
Department of Pharmaceutical Chemistry, Government College of Pharmacy, Bengaluru, Karnataka
India
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Source of Support: None, Conflict of Interest: None


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Aim: A simple, sensitive, precise, and rapid reverse phase high-performance liquid chromatography method was developed and validated for simultaneous estimation of sitagliptin (SIT) and simvastatin (SIM) in bulk drug and tablet dosage forms. Materials and Methods: The separation was achieved by using Prontosil 120-5-CN (250 mm × 4.6 mm, 5 μm) column with a mobile phase consisting of acetonitrile:methanol:phosphate buffer (45:10:45 v/v). The mobile phase was delivered at a flow rate of 1.0 ml/min. Analysis was performed at ambient temperature with detection at 254 nm. Results: The retention times of SIT and SIM were found to be 4.8 and 6.0 min and the calibration curves were linear (R2 = 0.999) over a concentration range from 1 to 30 μg/ml for SIT and SIM, respectively. Limit of detection and limit of quantitation were 0.6 μg/ml and 0.7 μg/ml for SIT and 0.1 μg/ml and 0.2 μg/ml for SIM, respectively. Conclusion: The developed method was validated for parameters such as system suitability, specificity, linearity, accuracy, precision, ruggedness, and robustness as per International Conference on Harmonization guidelines and the results were found to be within the limits. Hence, it can be used for the routine quality control of SIT and SIM in the bulk sample and tablet dosage forms.


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