Article Details

DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR SIMULTANEOUS ESTIMATION OF ROSUVASTATIN AND TENELIGLIPTIN IN THEIR SYNTHETIC MIXTURE

Minakshi M. Dhorua *, Maitri P. Parikha , Krunal K. Detholiab and Pathik J. Patelc

a Department of Pharmaceutical Quality Assurance, Smt. S. M. Shah Pharmacy College, Amsaran, Mahemdavad-387 130, Gujarat, India

b Department of Pharmaceutics, Smt. S. M. Shah Pharmacy College, Amsaran, Mahemdavad-387 130, Gujarat, India

c Department of Pharmacognosy, Smt. S. M. Shah Pharmacy College, Amsaran, Mahemdavad-387 130, Gujarat, India

For Correspondence: E-mail: minu.pharm@gmail.com

 

https://doi.org/10.53879/id.60.02.13015


ABSTRACT

A simple, fast and accurate Reverse Phase High Performance Liquid Chromatography method has been established and validated for estimation of rosuvastatin and teneligliptin in their synthetic mixture. The chromatographic separation was achieved on Agilent Inertsil Octa Decyl Silane (ODS) C18 (250 × 4.6 mm, 5 µm) column using mobile phase composition of methanol: water (pH=3 adjust with 10 % Orthophosphoric acid) (70:30 V/V), in isocratic mode at flow rate of 0.8 mL min-1 at a detection wavelength of 244 nm. In terms of precision, accuracy, limit of detection and limit of quantitation, the method was validated. Rosuvastatin and teneligliptin had retention times of 7.41 and 4.35 minutes, respectively. Rosuvastatin and teneligliptin were reported to have linearity of 5-15 µg mL-1 and 10-30 µg mL-1, respectively, with correlation coefficient (R2 ) value of 0.998 for rosuvastatin and 0.999 for teneligliptin. Method can be employed for study of rosuvastatin and teneligliptin in their mixture.

Year 2023 | Volume No. 60 | Issue No.2 | Page No. 60-69
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