DEVELOPMENT AND VALIDATION OF STABILITY-INDICATING RP-HPLC ASSAY METHOD FOR AZACITIDINE AND ITS BULK DRUG
Journal Title: International Journal of Pharmacy and Pharmaceutical Sciences - Year 2014, Vol 6, Issue 8
Abstract
Objective: A novel gradient reverse phase High Performance Liquid Chromatographic (HPLC) method was developed for the quantification of Azacitidine impurities and degradation products in the Azacitidine tablets.Methods: The effective separation was achieved on an YMC ODS AQ-5, (250 x 4.6 mm), 5 µm column using a gradient mode by the mobile phase A: 3.1g of ammonium acetate dissolved in 1000 mL of water filtered through 0.45μm filter paper and mobile phase B: mixture of buffer – A, methanol and acetonitrile In the ratio of 500:300:200 v/v. The flow rate of the mobile phase was 1.0 mL/minute and the total elution time, including the column equilibration was approximately 60 minutes. The UV detection was carried at the wavelength 242 nm and experiments were conducted at 35 0 C.Results: The retention times of Azacitidine and its impurities are 15.3, 3.9, 4.9, 25.0 and 33 respectively. Azacitidine tablets were subjected to the stress conditions of oxidation, acid, base, hydrolytic, thermal and light degradation. The assay method was found to be linear in the range of 400 μg·mL–1 to with 1000 μg·mL–1 correlation coefficient is 0.998 and the linearity of the impurities was established from LOQ to 150%. Recoveries of assay and impurities were found between 99.0% and 103.6%.Conclusion: The developed method was validated in terms of system suitability, specificity, linearity range, precision, accuracy, limits of detection and quantification for the impurities following the ICH guidelines. Therefore, the proposed method is suitable for the simultaneous determination of Azacitidine and its four related impurities.
Authors and Affiliations
Brahmaiah Marineni, T Sreenivasulu Reddy
Keywords
Related Articles
- EP ID EP579697
- DOI -
- Views 139
- Downloads 0
ASSESSMENT OF ANALGESIC ACTIVITY OF NELUMBO NUCIFERA FRUIT ETHANOL EXTRACT
Objective: Utilization of herbal remedies rich in flavonoids and vitamins have increased significantly these days to treat various disorders, thus existing research work encircled to appraise the analgesic effect of Nelu...
STUDY OF ANTIOXIDANT ACTIVITY OF FORMONONETIN BY IN VITRO METHOD
Objective: Now the important field of research in phytomedicine is to search a new plant source as well as new phytoconstituents that have fewer side effects and low cost with the free radical scavenging activity. Method...
ANTIBACTERIAL CAPACITY AND IDENTIFICATION OF BIOACTIVE COMPOUNDS BY GCMS OF ALLIUM CEPA
Objective: Plants offer a novel source for the isolation of a wide variety of medicinal agents. Allium cepa commonly known as onion is very well known medicinal plants and we investigated the antibacterial activity of di...
ISOLATION AND CHARACTERISATION OF NOVEL IMPURITY OF LANSOPRAZOLE FORMED IN THERMAL STRESS CONDITION
Objective: The aim of the research work is to study the degradation of Lansoprazole in stress condition which is a proton pump inhibitor and controls the production of gastric acid in stomach. Thermal stress condition ha...
JOB SATISFACTION OF PHARMACISTS IN ETHIOPIA: THE CASE OF HARAR TOWN
Objective: To assess job satisfaction of pharmacists in Harar town, Eastern Ethiopia.Methods: A prospective cross sectional study was conducted using the self administered questionnaire among pharmacy professionals worki...