STABILITY INDICATING RP-HPLC-PDA METHOD FOR DETERMINATION OF ABIRATERONE ACETATE AND CHARACTERIZATION OF ITS BASE CATALYZED DEGRADATION PRODUCT BY LC-MS
Journal Title: International Journal of Pharmacy and Pharmaceutical Sciences - Year 2016, Vol 8, Issue 2
Abstract
Objective: The present work describes stability indicating (SI) RP-HPLC-PDA method for determination of abiraterone acetate (ABA) and characterization of its base catalyzed degradation product by LC-MS.Methods: The separation was achieved by using column Kromasil C18 (250 mm × 4.6 mm, 4.0 µ) using acetonitrile (ACN): ammonium acetate buffer 10 mM, pH adjusted to 3.5 with acetic acid (AA) in the ratio of 10:90 % v/v as eluent. The Mobile phase flow rate was 0.6 ml/min and data integration was achieved at 235 nm.Results: The retention time of ABA was 5.4±0.01 min. Linearity was found to be in the range of 5–30 μg/ml. The limit of detection and quantitation were 0.25 μg/ml and 0.75 μg/ml respectively, and percentage recovery of ABA was found to be 99.52 to 100.13 %. Mass spectral data of base degraded product of ABA shows a prominent molecular ion peak at m/z-391.5. Major fragmentation leads to formation of 10–Methyl 2,3,4,7,8,9,10,11,12,13,14,15-dodecanhydro-1H cyclopenta (α)phenanthren-3-ol as a degradant (D2) at m/z-257.81, due to corresponding loss of C8H12ON. All the analytical validation parameters were determined and found in the limit as per ICH guidelines.Conclusion: The results of the various validation studies showed that the LC method is fast, specific, accurate, reproducible, possessed significant linearity and precision. The drug was found to be stable under all the stress conditions except basic stress. Thus developed method reported first time is novel with a very short run time of 6 min.Â
Authors and Affiliations
Gadhave R. V. , Tamnar A. B. , Bansode A. S. , Choudhari V. P.
Keywords
Related Articles
- EP ID EP577847
- DOI -
- Views 48
- Downloads 0
USE OF SOME ETHNOMEDICINAL HERBS BY THE NATIVES OF SOLANG VALLEY, KULLU DISTRICT, HIMACHAL PRADESH
Objective: The objective of the study was to enlist the ethnobotanical uses of wild plants of Solang Valley, Kullu District, Himachal Pardesh. Due to the specific geographical location of the valley, it possesses a high...
PROTECTIVE EFFECTS OF Α - CRYSTALLIN ON Β - AMYLOID (Aβ) INDUCED TOXICITY
Objectives: To investigate the protective role of α-crystallin against β-amyloid aggregation.Methods: In vitro spectroscopic methods and cell culture studies were done to validate our objective.Results: The molecular b...
A STUDY COMPARING THE ANORECTIC ACTIVITY OF HOT AND COLD AQUEOUS EXTRACTS OF DOLICHOS BIFLORUS LINN. SEEDS IN FREELY FEEDING RATS
Objective: The aim of the study was to evaluate the anorectic activity of hot (pre-cooked under pressure) and cold (soaked overnight) aqueous extracts of the seeds of D. biflorus in freely feeding Wistar albino rat model...
EFFECT OF ETHANOL STEM BARK EXTRACT OF BERLINIA GRANDIFLORA HUTCH AND DALZ ON MARKER LIVER ENZYMES IN RATS TREATED WITH CCl4
Objective: The objective of this work was to validate the traditional claim of the use of the stem bark of Berlinia grandiflora in treating liver problems by investigating the effect of its ethanol stem bark extract on m...
AWARENESS OF USAGE OF SUNSCREENS AMONG SCHOOL CHILDREN IN KANDY, SRI LANKA
Objective: The objective of this research was to evaluate the awareness of usage of sunscreens among school children in Kandy, Sri Lanka.Methods: School children (138) who do outdoor sports were recruited from six school...