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Development and validation of novel RP-HPLC method for the simultaneous determination of Rosuvastatin and Teneligliptin in bulk and in synthetic mixture
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| Author:
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, DRASHTI A.MANDALE, DR.CHAINESH SHAH, DR.RAKESH JATT
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| Abstract:
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The patients from Type 2 diabetes sometimes from increased lipid levels and increased hypertension also.
These conditions may cause several complications and it requires multidrug therapy in single dose regimen. So
combination of Rosuvastatin and Tenegliptin fulfill these requirements with minimum risk factors. The aim of
the present study was to develop and validate a simple, rapid and reproducible gradient high performance
reverse phase liquid chromatography method for the estimation of Rosuvastatin and Tenegliptin in bulk drug
sample and in synthetic mixture using Luna C18 100A0(250mm×4.6mm i.d. 5 µm) column kept at 25°C and UV
detection at 240nm. The compounds were eluted gradiently at a flow rate of 1.0ml/min. The average retention
times for Teneligliptin and Rosuvastatin were 2.583 and 5.458 min, respectively. The calibration curves were
linear (r2 > 0.9999) over the concentration range 10-200µg/ml for Teneligliptin and 10-200µg/ml for
Rosuvastatin. No spectral or chromatographic interferences from formulation excipients were found and
hence it was successfully applied for the determination of Teneligliptin and Rosuvastatin in bulk and in synthetic
mixture. The accuracy of the proposed method was determined by recovery studies and found to be 98-101%.
The proposed method was validated and results conformed to ICH parameters.
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| Keyword:
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accuracy, calibration curve, LOD, LOQ, precision, retention time
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| EOI:
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| DOI:
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https://doi.org/10.31838/ijpr/2021.13.03.061
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| Download:
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