Adluri, Phanindra <br/><br/>
DEVELOPMENT AND VALIDATION OF SENSITIVE LC-ESI-MS/M S METHOD FOR THE  SIMULTANEOUS ESTIMATION OF DAPAGLIFLOZIN AND SAXAGL IPTIN IN HUMAN PLASMA  

 - Vol.11(4) 
 - M P  Innovare Academic Sciences Pvt Ltd  2019 
 - 55-59p. 
<br/><br/> Objective<br/>:<br/>To  develop  and  validate  a  sensitive  liquid  chromato<br/>graphy-electrospray  ionization-tandem  mass  spectrom<br/>etric  (LC-ESI-MS/MS) <br/>technique for the quantification of dapagliflozin a<br/>nd saxagliptin in plasma by linagliptin as internal<br/> standard.  <br/>Methods<br/>:<br/>Chromatography was achieved on hypersil C<br/>18<br/> (50 mmx4 mm) 5 μ analytical column with 0.1% formi<br/>c acid and acetonitrile (25:75 V/V) <br/>as mobile phase at 0.7 ml/min flow rate. Dapagliflo<br/>zin, saxagliptin, and linagliptin were detected at <br/>m/z 409.14/135.0, m/z 316.2/180.13 and m/z <br/>472.54/456.21 respectively. Drugs and internal stan<br/>dard were extracted by LLE (liquid-liquid extractio<br/>n). <br/>Results<br/>:<br/>Developed  technique  was  validated  over  0.5-1500.0  n<br/>g/ml  linear  concentration  range  for  dapagliflozin  a<br/>nd  2.00-2000.0  ng/ml  for <br/>saxagliptin. This method established with intra-bat<br/>ch and inter-batch precision within 2.44-8.12% and <br/>1.25-7.14 % for dapagliflozin and 1.84-7.5 % <br/>and 1.02–6.00 % for saxagliptin. This method establ<br/>ished with intra-batch and inter-batch accuracy for<br/> dapagliflozin within 98.86-103% and 96.98-<br/>102 % respectively and for saxagliptin within 98.05<br/>-109.06 % and 97.00-104.00 % respectively. <br/>Conclusion<br/>:<br/>Both  dapagliflozin  and  saxagliptin  were  stable  duri<br/>ng  three  freeze-thaw  cycles,  long  term  and  bench-to<br/>p  stability  studies.  The <br/>developed method was useful for the routine analysi<br/>s of dapagliflozin and saxagliptin simultaneously i<br/>n plasma samples.  
<br/><br/><label>Subjects--Topical Terms: </label><br/>PHARMACEUTICS