Abstract
A simple and available reversed-phase high performance liquid chromatography (HPLC) method with UV detection has been developed and validated for mycophenolic acid (MPA) assay in human plasma. MPA was extracted from plasma with protein precipitation method by acetonitrile: percholeric acid: methanol (75:5:20 v/v/v). The drug separation was achieved using a C8 analytical column and a mobile phase of 0.1M triethylammonium phosphate (pH=5.4)-acetonitril (65:35, v/v), with a flow rate of 1.5 ml/min. The detection wavelength was 304 nm. Limit of detection (LOD) of the method was determined as the lowest MPA concentration producing a signal-to-noise (S/N) ratio of about 3. Limit of quantitation (LOQ) was determined as the lowest MPA concentration capable of being quantitated with enough accuracy and precision. The method showed significant linear response-concentration relationship throughout the MPA concentration range of 0.2-10 µg/ml. A typical linear regression equation of the method was: y = 8.5523 x + 0.094, with x and y representing MPA concentration (in µg/ml) and peak height respectively, and the regression coefficient (r) of 0.9816. The average within-run and between-run variations of 7.81 and 4.78 percent. The average drug recovery from plasma was 95.24 percent throughout the linear concentration range. The limits of detection (LOD) and quantitation (LOQ) of the method were 0.05 and 0.2 µg/ml, respectively. The practical applicability of the method was proven throughout a bioequivalence study. The results showed the acceptable degree of linearity, sensitivity, precision, accuracy and recovery for the method. The method was used successfully for quantitation of MPA in plasma samples of healthy volunteers throughout a bioequivalence study.
Highlights
Mycophenolic acid (MPA) is an immunosuppressant drug that has been widely and successfully used in transplant recipients as well as in patients with immune disorders.[1,2] mycophenolic acid (MPA) is administered as either an ester prodrug or a sodium salt and is extensively metabolized by UDP-glucuronosyltransferases (UGTs) to two glucuronidated metabolites
More sensitive methods for MPA assay in plasma have been developed, but they used liquid chromatography with tandem mass spectrometry.[17,18]
Mycophenolic acid assay in plasma group, the 500 mg cellcept formulation was administered and blood samples were obtained prior to dose administration and at 0.25, 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 10.0 and 24.0 h after the dose
Summary
Mycophenolic acid (MPA) is an immunosuppressant drug that has been widely and successfully used in transplant recipients as well as in patients with immune disorders.[1,2] MPA is administered as either an ester prodrug or a sodium salt and is extensively metabolized by UDP-glucuronosyltransferases (UGTs) to two glucuronidated metabolites. Mycophenolic acid (MPA, Figure 1) derivatives (Cellcept® or Myfortic®) choice in renal transplantation in combination with a calcineur in inhibitor and steroids.[3] Their introduction in clinical medicine represented an advance because they improve graft survival rates. Optimal use of these new immunosuppressive drugs requires knowledge of their pharmacobiology. The ratio between the free and bound components is affected by a variety of conditions including renal insufficiency and concomitant cyclosporin, tacrolimus or steroid therapy.[4,5,6] These variables are commonly present in transplant patients, a situation that argues for monitoring of MPA level. The distinct advantages of this method over other reported methods include its simplicity, inexpensive and the method’s reproducibility
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