Study On The Quality Standard For Escitalopram Oxalate And Its Tablet

To develop the quality standard of the Escitalopram Oxalate and its tablets. Method:The molecule structure of the Escitalopram Oxalate was validated by analyse of DR., VU, NMR and MS. To describe outward appearance and determine constants of physics and chemistry of Escitalopram Oxalate, according to methods of pharmacopoeia. IR, UV, HPLC and property experiment of Oxalate were used in the identification test. To separate the enantiomers of Citalopram Oxalate and determinate R-citalopram Oxalate was performed by HPLC on a CHIROBIOTIC V column. A rapid high-performance liquid chromatographic method used to determine the contents of Escitalopram Oxalate and its tablets and relevant substance on C18 column was described. A gas chromatography method was established to determine of the residual organic volatile solvents in Escitalopram Oxalate with a HP-INNOWAX column. To Determination of dissolution and uniformity was performed by Ultraviolet spectroscopy. Paddle method was used to determine dissolution. The rotation speed was 50 r min-1 and the dissolution medium was water. Result:Accuracy of Escitalopram Oxalate construction was proved. Escitalopram Oxalate outward appearance form is: White or light yellow powder, having no smelly, tasteless; the melting range: between 151C and 155 C . Escitalopram Oxalate was dissolved easily in methanol and dimethyl sulfoxide(DMSO), dissolved slightly in waterand ethanol, and dissolved tiny in ethyl acetate. Escitalopram Oxalate increasing weight 1.867%, after it was deposited in condition of high humidity. Relevant substance was controlled not more than 1.0%. The enantiomers of Citalopram Oxalate could be completely separated (R>1.5). The regression equation for Escitalopram Oxalate was As = 40224.778Cs+55.066 ( r = 0.9991, n=5) over the range of: 0.01 ~0.25mg/ml, and the regression equation for R-citalopram Oxalate was Ar = 1764.083CR+0.856, (r=0.9993, n=5 ) . This method allows accurate quantification for S- and R- citalopram Oxalate. R-citalopram Oxalate was requested not more than 5%. Only not more than 0.05% ethanol was found in determination of the residual organic volatile solvents. The other organic volatile solvents were not found in sample. Contents of Escitalopram Oxalate in production was 101.30% 100.46% and 99.60% ( RSD<1.30% ) . It was suitable for quantification criterion. Ultraviolet spectroscopy was validated, and the excipients did not interfere with determination of its tablets. The standard curve was linear within the range of 0.002-0.030 mg/ml with the correlation coefficient of 0.9998. The drug dissolution at 30min was above 80%. The results of study on uniformity show that its tablets accord with request of pharmacopoeia (A+1.8S<8) . Contents of the tablets in production was accurate. The average recovery was 99% with a relative standard deviation of 1.19%. Conclusion:The quality standard can be used to evaluate and control effectively the quality of Escitalopram Oxalate. Escitalopram Oxalate and its tablets conform to the quality requirements under new drug and its tablets of pharmacopoeia of P. R. China (part II, Edi2ooo)...