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 has also been reported. Olaparib molecular weight 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 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��. 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.
The use of modern apparatus such as video scanners, densitometers, and new chromatographic chambers, more effective elution techniques and high-resolution sorbents with selected particle size or chemically modified surface, the possibility of combining with other instrumental methods, and the development of computer programs for method optimization make HPTLC an important alternative method to HPLC or gas chromatography. Specifically, HPTLC is one of the ideal TLC techniques for analytical purposes because of its increased accuracy, reproducibility, and ability to document the results, compared with standard TLC. Because of this, HPTLC technologies are also the most appropriate TLC techniques for conformity with Good Manufacturing Practices (GMPs). Today, the comprehensive use of TLC in pharmaceutical analysis is demonstrated by the great number of articles published in this field. So the ultimate aim of the present study is to develop and validate the HPTLC method for the determination of mycophenolate mofetil in bulk drug and dosage form.
The optimization of the method separation, validation parameters, and quantification of mycophenolate mofetil as bulk and as formulation are reported in the following sections. MATERIALS AND METHODS Chemicals Carfilzomib and reagents The authentic sample of mycophenolate mofetil was procured from Intas Pharmaceuticals Ltd., Ahmedabad. The pure drug obtained had 99.9% w/w assay value, and was used without further purification.