RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS ESTIMATION OF ERTUGLIFLOZIN AND SITAGLIPTIN IN BULK AND TABLET DOSAGE FORMS

M. Laxmi, R . V. Valli Kumari, S. Marakatham, M. Sathish Kumar

Abstract


This  investigation  furnishes  an  analytical  method  on  reverse  phase  high  performance  liquid  chromatography  with  PDA  detection  method  for  the  simultaneous  determination  ertugliflozin  and  sitagliptin  in  bulk  and  in   its  tablets.  The  separation  and  assay  of  ertugliflozin  and  sitagliptin  was  done  using  Cosmicsil  C8  column  (250 mm × 4.6 mm I.D., 5 μm size particle)  in  isocratic  mode  of  elution . The  optimized  mobile  phase  was  0.1  Molar  dipotassium  hydrogen  phosphate  and  methanol  (65:35, v/v).  The  eluted  analytes  are  monitored  at  225  nm  wavelength.  The  method  separated  ertugliflozin  and  sitagliptin  within   a  7  min  run  time.  The  parameters  proposed  by  International  Conference  of  Harmonization  guidelines  were  concluded  by  validation  i.e.,  system  suitability , linearity , limit  of  detection , limit  of  quantification , selectivity , accuracy  precision  and  robustness . Linearity  of  ertugliflozin  and  sitagliptin  was  in  concentration  range  of  7.5 -22.50  µg/ml  and  50-150  µg/ml , respectively  by  the  method . The  LOD  was  0.087  and  0.071  μg/ml  for  sitagliptin  and  ertugliflozin , respectively . The  LOQ  was  0.291  μg/ml  and  0.237  μg/ml  for  sitagliptin  and  ertugliflozin,  respectively . The  developed  method  was  assessed  through  analysis  of  sitagliptin  and  ertugliflozin  in  the  available  tablet  dosage  form . The  percent  recoveries  (± RSD)  were  99.60  ±  0.027  and  99.83  ±  0.017  for  sitagliptin  and  ertugliflozin , respectively.  The  results  proved  the  non  interference  from  the  tablet  excipients  with  good  recovery  and  precision . Hence   the method  can  be  suggested  for  the  routine  quality  control  analysis  of  sitagliptin  and  ertugliflozin.   


Keywords


Ertugliflozin, Sitagliptin, RP-HPLC, Method development

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