The developed method was validated as par ICH guidelines. selleckchem Statistical analysis proved that the method is repeatable and selective for the analysis of TELM and METO in combination as a single drug in bulk as well as in pharmaceutical formulations. ACKNOWLEDGMENT The authors are thankful to Corona Zydus Cadila Healthcare Ltd. Ahmedabad, Gujarat, India for providing gift sample of TELM and METO for research. The authors are highly thankful to Shri Sarvajanik Pharmacy College, Mehsana, Gujarat, India for providing all the facilities to carry out the work. Footnotes Source of Support: Nil Conflict of Interest: None declared.
Mycophenolate mofetil is chemically 2-(morpholin-4-yl) ethyl (4E)-6-(4-hydroxy-6-methoxy-7-methyl-3-oxo-1,3-dihydroisobenzofuran-5-yl)-4-methylhex-4-enoate.
[1] Mycophenolate mofetil [Figure 1] is an immunosuppressant and prodrug of mycophenolic acid, extensively used to prevent rejection in organ transplantation. It acts as a noncompetitive, selective, and reversible inhibitor of inosine monophosphate dehydrogenase (IMPDH) in purine biosynthesis, guanine synthesis to be specific, which is necessary for the growth of T cells and B cells. A few high-performance liquid chromatography (HPLC)[2�C7] and liquid chromatography�Cmass spectrometry (LC-MS)[8,9] methods for its determination have been reported. A simultaneous determination of mycophenolic acid and valproic acid in human plasma by HPLC[10] has also been reported.
Figure 1 Structure of mycophenolate mofetil No high-performance thin layer chromatography (HPTLC) method for the quantitative analysis of mycophenolate mofetil as bulk and as formulation or for stability studies was found by a computer-assisted survey of the literature Batimastat either from chemical abstracts or by using the CAMAG Bibliography Service. Hence, the main objective of the work discussed in this paper was to develop a rapid and reliable HPTLC method for the analysis of mycophenolate mofetil in bulk and its dosage form. The method was validated in accordance with the guidelines of the International Conference on Harmonization (ICH) International Conference on Harmonization and remove ��o��.[11] Here we describe the investigation in detail. The usage of HPTLC is well appreciated and accepted all over the world. Many methods are being established to standardize the assay methods. HPTLC remains one step ahead when compared with other tools of chromatography. HPTLC is used for the identification of constituents, determination of impurities, and quantitative determination of active substances.