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The aim of the present research work is to provoke a validated, sensitive and highly selective LC-MS/MS method for the determination of potential genotoxic impurity namely Sacubitril Ene Ester (SEE) impurity in sacubitril/valsartan drug substance at ppm level.The LC-MS/MS method was developed on waters X-Bridge Ph (150mm x 4.6 mm) 3.5μm in gradient elution at 30°C.Mobile phase-A was 10mM ammonium acetate and mobile phase-B was acetonitrile: methanol: water (60:30:10, %volume/volume/v) at a constant flow rate and injection volumes are of 0.8 mL/min and 10μL resp. with 30 min gradient run time monitored by mass spectrophotometer.Validation was performed on basis of the standard guideline "International Conference on Harmonization" (ICH) guideline Q2(R1).LC-MS/MS is able to quantitate up to 1.1ppm of SEE impurity.Under these LC and MS conditions, SEE impurity was quantified by multiple reaction monitoring pair (most stable ions) m/z of 408.1/262.2.This method has been used for testing and quant. determination of SEE impurity in sacibitril/valsartan samples at μg levels.The developed LC-MS/MS method was validated and the resulting data found to show the specificity, linearity, accuracy and precision of the proposed methodol.Further the results show that the developed LC-MS/MS method was well suited to quantify the SEE potential genotoxic impurity.

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