Impurity profile study of loratadine.
Three unknown impurities in loratadine bulk drug at levels below 0.1% (ranging from 0.05 to 0.1%) were detected by a simple isocratic reversed-phase high performance liquid chromatography (HPLC). These impurities were isolated from mother liquor sample of loratadine using reversed-phase preparative HPLC. Based on the spectral data (IR, NMR and MS) the structures of these impurities were characterized as 11-(N-carboethoxy-4-piperidylidene)-6,11-dihydro-5H-benzo(5,6) cyclopenta(1,2-b)-pyridine (I), 8-bromo-11-(N-carboethoxy-4-piperidylidene)-6,11-dihydro-5H-benzo(5,6) cyclopenta (1,2-b)-pyridine (II) and 8-chloro-11-(N-carboethoxy-4-piperidylidene)-5H-benzo(5,6) cyclopenta (1,2-b)-pyridine (III). The synthesis of these impurities was discussed.
Reddy
K V S R Krishna
KV
Department of Analytical Research, Discovery Research Division, Dr Reddy's Laboratories Ltd., Bollaram Road, Miyapur, Hyderabad 500 050, India.
Babu
J Moses
JM
Kumar
Y Ravindra
YR
Reddy
S Vishnu Vardhan
SV
Kumar
M Kishore
MK
Eswaraiah
S
S
Reddy
K Rama Subba
KR
Reddy
M Sayanarayana
MS
Bhaskar
B Vijaya
BV
Dubey
P K
PK
Vyas
K
K
D002851:Chromatography, High Pressure Liquid; D004340:Drug Contamination; D039563:Histamine H1 Antagonists, Non-Sedating / Q000032:analysis / Q000737:chemistry*; D017336:Loratadine / Q000032:analysis / Q000737:chemistry*; D009682:Magnetic Resonance Spectroscopy; D013058:Mass Spectrometry; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D017550:Spectroscopy, Fourier Transform Infrared
D039563:Histamine H1 Antagonists, Non-Sedating; D017336:Loratadine