Identification and characterization of degradation products of dicloxacillin in bulk drug and pharmaceutical dosage forms

2007 ◽  
Vol 43 (4) ◽  
pp. 1470-1475 ◽  
Author(s):  
T. Joseph Sunder Raj ◽  
C.H. Bharati ◽  
K. Ranga Rao ◽  
P. Satyanarayana Rao ◽  
G.K.A.S.S. Narayan ◽  
...  
Keyword(s):  
Degradation Products ◽  
Dosage Forms ◽  
Pharmaceutical Dosage Forms ◽  
Bulk Drug ◽  
Identification And Characterization

Identification, Characterization, and Quantification of Impurities of Safinamide Mesilate: Process-Related Impurities and Degradation Products

2017 ◽  
Vol 100 (4) ◽  
pp. 1029-1037 ◽  
Author(s):  
Liang Zou ◽  
Lili Sun ◽  
Hui Zhang ◽  
Wenkai Hui ◽  
Qiaogen Zou ◽  
...  
Keyword(s):  
Degradation Products ◽  
Hplc Method ◽  
Formation Mechanisms ◽  
Stability Indicating ◽  
Related Impurities ◽  
Related Substances ◽  
Water Ph ◽  
Bulk Drug ◽  
First Time

Abstract The characterization of process-related impurities and degradation products of safinamide mesilate (SAFM) in bulk drug and a stability-indicating HPLC method for the separation and quantification of all the impurities were investigated. Four process-related impurities (Imp-B, Imp-C, Imp-D, and Imp-E) were found in the SAFM bulk drug. Five degradation products (Imp-A, Imp-C, Imp-D, Imp-E, and Imp-F) were observed in SAFM under oxidative conditions. Imp-C, Imp-D, and Imp-E were also degradation products and process-related impurities. Remarkably, one new compound, identified as (S)-2-[4-(3-fluoro-benzyloxy) benzamido] propanamide (i.e., Imp-D), is being reported here as an impurity for the first time. Furthermore, the structures of the aforementioned impurities were characterized and confirmed via IR, NMR, and MS techniques, and the most probable formation mechanisms of all impurities proposed according to the synthesis route. Optimum separation was achieved on an Inertsil ODS-3 column (250 × 4.6 mm, 5 μm), using 0.1% formic acid in water (pH adjusted to 5.0) and acetonitrile as the mobile phase in gradient mode. The proposed method was found to be stability-indicating, precise, linear, accurate, sensitive, and robust for the quantitation of SAFM and its process-related substances, including its degradation products.

Chiral Separation of (R,R)-Tadalafil and Its Enantiomer in Bulk Drug Samples and Pharmaceutical Dosage Forms by Chiral RP-LC

2008 ◽  
Vol 67 (7-8) ◽  
pp. 633-638 ◽  
Author(s):  
A. Madhavi ◽  
G. S. Reddy ◽  
M. V. Suryanarayana ◽  
A. Naidu
Keyword(s):  
Chiral Separation ◽  
Dosage Forms ◽  
Pharmaceutical Dosage Forms ◽  
Bulk Drug
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