Although a number of methods are available for evaluating Linezolid and its possible impurities, a common method for separation if its potential impurities, degradants and enantiomer in a single method with good effic...Although a number of methods are available for evaluating Linezolid and its possible impurities, a common method for separation if its potential impurities, degradants and enantiomer in a single method with good efficiency remain unavailable. With the objective of developing an advanced method with shorter runtimes, a simple, precise, accurate stability-indicating LC method was developed for the determination of purity of Linezolid drug substance and drug products in bulk samples and pharmaceutical dosage forms in the presence of its impurities and degradation products. This method is capable of separating all the related substances of Linezolid along with the chiral impurity. This method can also be used for the estimation of assay of Linezolid in drug substance as well as in drug product. The method was developed using Chiralpak IA (250 mm 4.6 mm, 5 mm) column. A mixture of acetonitrile, ethanol, n-butyl amine and trifluoro acetic acid in 96:4:0.10:0.16 (v/v/v/v) ratio was used as a mobile phase. The eluted compounds were monitored at 254 nm. Linezolid was subjected to the stress conditions of oxidative, acid, base, hydrolytic, thermal and photolytic degradation. The degradation products were well resolved from main peak and its impurities, proving the stability-indicating power of the method. The developed method was validated as per International Conference on Harmonization (ICH) guidelines with respect to specificity, limit of detection, limit of quantification, precision, linearity, accuracy, robustness and system suitability.展开更多
For the stability problem of homogeneous shear flows in sea straits of arbitrary cross section, a sufficient condition for stability is derived under the condition of inviscid flow. It is shown that there is a critica...For the stability problem of homogeneous shear flows in sea straits of arbitrary cross section, a sufficient condition for stability is derived under the condition of inviscid flow. It is shown that there is a critical wave number, and if the wave number of a normal mode is greater than this critical wave number, the mode is stable.展开更多
We consider inviscid,incompressible shear flows with variable density and variable cross section.For this problem,we derived a new estimate for the growth rate of an unstable mode and a parabolic instability region wh...We consider inviscid,incompressible shear flows with variable density and variable cross section.For this problem,we derived a new estimate for the growth rate of an unstable mode and a parabolic instability region which intersects semiellipse instability region under some condition.展开更多
文摘Although a number of methods are available for evaluating Linezolid and its possible impurities, a common method for separation if its potential impurities, degradants and enantiomer in a single method with good efficiency remain unavailable. With the objective of developing an advanced method with shorter runtimes, a simple, precise, accurate stability-indicating LC method was developed for the determination of purity of Linezolid drug substance and drug products in bulk samples and pharmaceutical dosage forms in the presence of its impurities and degradation products. This method is capable of separating all the related substances of Linezolid along with the chiral impurity. This method can also be used for the estimation of assay of Linezolid in drug substance as well as in drug product. The method was developed using Chiralpak IA (250 mm 4.6 mm, 5 mm) column. A mixture of acetonitrile, ethanol, n-butyl amine and trifluoro acetic acid in 96:4:0.10:0.16 (v/v/v/v) ratio was used as a mobile phase. The eluted compounds were monitored at 254 nm. Linezolid was subjected to the stress conditions of oxidative, acid, base, hydrolytic, thermal and photolytic degradation. The degradation products were well resolved from main peak and its impurities, proving the stability-indicating power of the method. The developed method was validated as per International Conference on Harmonization (ICH) guidelines with respect to specificity, limit of detection, limit of quantification, precision, linearity, accuracy, robustness and system suitability.
基金Project supported by the Natural Science Foundation of Zhejiang Sci-Tech University(No.11130032241201)
文摘For the stability problem of homogeneous shear flows in sea straits of arbitrary cross section, a sufficient condition for stability is derived under the condition of inviscid flow. It is shown that there is a critical wave number, and if the wave number of a normal mode is greater than this critical wave number, the mode is stable.
文摘We consider inviscid,incompressible shear flows with variable density and variable cross section.For this problem,we derived a new estimate for the growth rate of an unstable mode and a parabolic instability region which intersects semiellipse instability region under some condition.
