Speaker Biography


Islamic University, Bangladesh

Title: Analytical Method Validation of RP-HPLC Method for Simultaneous Estimation of Levonorgestrel and Ethinylestradiol from Combined Drug Product



The aim  of recent study  is  to  explore a rapid,  sensitive and selective Reversed. Phase  HPLC  method  for  simultaneous  quantification  of  steroidal  hormones Levonorgestrel   and   Ethinylestradiol   from   drug   products.  Chromatographic separation of Levonorgestrel and Ethinylestradiol were achieved by Kromasil C8  column (4.6mm×150mm, 5μm) at 4.8 and 3.9 min by  using  60:40  volume of acetonitrile and  deionized water  mobile phase at  a flow rate of 1.0 ml/min at wavelength of 247nm and 310 nm respectively. The injection volume was 100μL and   the   column   temperature   was   maintained   at   25°C.   The   method   was validated according  to  USP  category  I requirements  which  includes  specificity, accuracy, precision, intermediate precision, linearity and range and robustness. The standard calibration curve were found linear (r 2 >0.99) over the analytical range throughout the analysis day. Precision and intermediate precision was < 3%  for  Levonorgestrel  and  Ethinylestradiol  at  QC  standard  range.  The  method was  found to  be accurate in  the range of 50  to  150%  from  QC  standard.  This method was also found robust in accordance with variation in the flow rate (±0.5  ml/min.),  organic  phase  ratio  (±10%),  change  column  oven  temperature (±5°C),  auto sampler  temperature (5°C  and 25°C) and changing column  brand. The   HPLC   method   was   successfully   applied   to   the  analysis   of   dissolution samples of marketed Levonorgestrel and Ethinylesradiol combined tablets