A A VALIDATED REVERSE-PHASE HIGH-PERFORMANCE LIQUID CHROMATOGRAPHY-CHARGED AEROSOL DETECTOR TECHNIQUE FOR THE SIMULTANEOUS ESTIMATION OF SITAGLIPTIN AND ERTUGLIFLOZIN IN PURE AND PHARMACEUTICAL DOSAGE FORMS
Objective: The main objective of the present work is to develop and validate a selective reverse-phase (RP) high-performance liquid (HPLC)-charged aerosol detection technique for the quantitation of the sitagliptin and ertugliflozin in dosage form to attain high degree of sensitivity.
Materials and Methods: In present HPLC technique, separation of drugs was achieved on Phenomenex C18 column (250×4.6 mm, 5 μ) with a mobile phase composition of phosphate buffer (pH – 5.8), acetonitrile, and methanol in the proportion of 40:40:20%V/V. 1 ml/min flow rate and 256 nm wavelength detection were maintained for the elution of drugs in the chromatographic system. The retaining time of sitagliptin and ertugliflozin in column was found to be 4.2 and 2.4 min, respectively.
Results: The projected technique was successfully applied for the quantitation of sitagliptin and ertugliflozin as a single combined mixture. The linearity statistics for calibration curves shown a good linearity in the concentration range of 0.3125–10 μg/ml for sitagliptin and 0.0625–2.5 μg/ml for ertugliflozin. The average values of regression coefficient, slope, and intercept were 0.9998, 8688.2, and 1977.6 for sitagliptin and 0.9996, 33602, and 1852.6 for ertugliflozin. The technique was validated as per the International Council for Harmonization guidelines. The limit of detection and limit of quantification findings were 0.082 and 0.247 μg/ml for sitagliptin and 0.04 and 0.12 μg/ml for ertugliflozin.
Conclusion: The developed and validated RP-HPLC-charged aerosol detector technique of sitagliptin and ertugliflozin in dosage form showed that the method was accurate and selective with high degree of sensitivity.
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