Lamivudine was subjected to forced decomposition conditions of hydrolysis (neutral, acidic and alkaline), oxidation, photolysis and thermal stress, as suggested in the ICH guideline Q1A(R2). The drug showed instability in acid and alkali, while it remained stable in neutral conditions. It also degraded extensively under oxidative environment. It remained stable to light and thermal stress. In total, five degradation products were formed, which could be separated by LC on a C18 column using a gradient method. To characterize the products, first a complete fragmentation pathway of the drug was established by carrying out multi-stage (MSn) and MS/TOF accurate mass studies. The same was compared to fragment pattern of the degradation products resulting from LC–MS/TOF studies. The accurate mass values obtained from LC–MS/TOF were used to obtain elemental compositions, and the total information helped in identification of the degradation products. Subsequently, degradation pathway of the drug was laid down, along with mechanisms of formation of the degradation products. There is no previous information on these aspects on the drug in the literature.

Study of forced decomposition behavior of lamivudine using LC, LC-MS/TOF and MS(n) / Bedse, Gaurav; Vijay, Kumar; Saranjit, Singh. - In: JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS. - ISSN 0731-7085. - ELETTRONICO. - 49:1(2009), pp. 55-63. [10.1016/j.jpba.2008.10.002]

Study of forced decomposition behavior of lamivudine using LC, LC-MS/TOF and MS(n)

BEDSE, GAURAV;
2009

Abstract

Lamivudine was subjected to forced decomposition conditions of hydrolysis (neutral, acidic and alkaline), oxidation, photolysis and thermal stress, as suggested in the ICH guideline Q1A(R2). The drug showed instability in acid and alkali, while it remained stable in neutral conditions. It also degraded extensively under oxidative environment. It remained stable to light and thermal stress. In total, five degradation products were formed, which could be separated by LC on a C18 column using a gradient method. To characterize the products, first a complete fragmentation pathway of the drug was established by carrying out multi-stage (MSn) and MS/TOF accurate mass studies. The same was compared to fragment pattern of the degradation products resulting from LC–MS/TOF studies. The accurate mass values obtained from LC–MS/TOF were used to obtain elemental compositions, and the total information helped in identification of the degradation products. Subsequently, degradation pathway of the drug was laid down, along with mechanisms of formation of the degradation products. There is no previous information on these aspects on the drug in the literature.
2009
Lamivudine, Stress studies, Stability-indicating assay method, MSn, LC–MS/TOF, Degradation pathway, Mechanism
01 Pubblicazione su rivista::01a Articolo in rivista
Study of forced decomposition behavior of lamivudine using LC, LC-MS/TOF and MS(n) / Bedse, Gaurav; Vijay, Kumar; Saranjit, Singh. - In: JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS. - ISSN 0731-7085. - ELETTRONICO. - 49:1(2009), pp. 55-63. [10.1016/j.jpba.2008.10.002]
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/11573/559884
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