A validated stability-indicating UPLC method for desloratadine and its impurities in pharmaceutical dosage forms.
A novel stability-indicating gradient reverse phase ultra-performance liquid chromatographic (RP-UPLC) method was developed for the determination of purity of desloratadine in presence of its impurities and forced degradation products. The method was developed using Waters Aquity BEH C18 column with mobile phase containing a gradient mixture of solvents A and B. The eluted compounds were monitored at 280nm. The run time was 8min within which desloratadine and its five impurities were well separated. Desloratadine was subjected to the stress conditions of oxidative, acid, base, hydrolytic, thermal and photolytic degradation. Desloratadine was found to degrade significantly in oxidative and thermal stress conditions and stable in acid, base, hydrolytic and photolytic degradation conditions. The degradation products were well resolved from main peak and its impurities, thus proved the stability-indicating power of the method. The developed method was validated as per ICH guidelines with respect to specificity, linearity, limit of detection, limit of quantification, accuracy, precision and robustness. This method was also suitable for the assay determination of desloratadine in pharmaceutical dosage forms.
Rao
Dantu Durga
DD
Dr. Reddy's Laboratories Ltd., IPDO, Bachupally, Hyderabad 500072, A.P, India. dantu_durga@yahoo.com
Satyanarayana
N V
NV
Malleswara Reddy
A
A
Sait
Shakil S
SS
Chakole
Dinesh
D
Mukkanti
K
K
D002626:Chemistry, Pharmaceutical / Q000379:methods / Q000592:standards*; D002853:Chromatography, Liquid / Q000379:methods / Q000592:standards; D004304:Dosage Forms / Q000592:standards; D004340:Drug Contamination; D004355:Drug Stability; D017336:Loratadine / Q000031:analogs & derivatives* / Q000032:analysis / Q000592:standards; D019999:Pharmaceutical Solutions / Q000032:analysis / Q000592:standards
D004304:Dosage Forms; D019999:Pharmaceutical Solutions; D017336:Loratadine; C121345:desloratadine