STABILITY INDICATING HPLC METHOD FOR THE ESTIMATION OF CINACALCET HYDROCHLORIDE API
Journal Title: Indian Journal of Research in Pharmacy and Biotechnology - Year 2013, Vol 1, Issue 3
Abstract
A stability-indicating liquid chromatography method has been developed and validated for the determination of Cinacalcet hydrochloride in a laboratory mixture as well as in a tablet formulation developed in-house. Efficient chromatographic separation was achieved on phenomenex C18 column (150 mm×4.6 mm, 5.0 μm) with mobile phase containing Methanol: Water (70:30v/v) pH adjusted to 3.6 with dilute Orthophosphoric acid at a flow rate of 1.3 mL/min and the eluent was monitored at 271 nm using Shimadzu LC-10AT-VP & LC-20 AD with Spinotech (Winchrome) software. Linearity range was found to be between 50-300μg/ml and the linear regression coefficient was not more than 0.999. The values of % RSD are less than 2% indicating accuracy and precision of the method. The percentage recovery varies from 97-103%w/w. LOD and LOQ were found to be within limit. The system suitability parameters like tailing factor, number of theoretical plates, Asymmetry were found to be within limit. Forced degradation studies were performed by using this method. There was a significant degradation in the presence of 0.1M HCl, 0.1M NaOH, 30%H2O2, heat and light. The proposed method is simple, accurate and rapid and hence can be employed for routine quality control analysis.
Authors and Affiliations
Manikandan Krishnan, Santhana Lakshmi Karunanidhi, Gayathri Sola, Akshitha . Y
Keywords
Related Articles
- EP ID EP33075
- DOI -
- Views 353
- Downloads 0
ANTINOCICEPTIVE AND ANTI-INFLAMMATORY ACTIVITY OF TECOMA STANS LEAF EXTRACTS
Tecoma stans (Bignoniaceae) is used in the treatment of diabetes, stomach pains, rheumatism, diuretic, vermifuge and tonic in traditional medicine. The present study has been design to evaluate antinociceptive and anti...
Development and validation of new RP-HPLC method for simultaneous estimation of drug Cefixime and Azithromycin in tablet dosage form
A simple, economic, accurate and precise reverse phase high performance liquid chromatography method for analysis of Cefixime and Azithromycin was developed and validated according to ICH guidelines. The quantification...
Synthesis, characterization and antimicrobial activity of di-nitro benzil by conventional and microwave irradiation methods
Microwave induced organic reaction enhancement (MORE) is a simple, clean, fast, efficient & economical method for the synthesis of organic molecules and has emerged as a tool towards green chemistry. Dinitro Benzil was...
Design and characterization of nanoparticulate drug delivery system of an anticancer drug: Imatinib mesylate
The present study was aimed to develop a nanoparticulate drug delivery system of Imatinib mesylate using a biodegradable polymer such as poly lactic acid (PLA). The design of Imatinib mesylate nanoparticles is proposed...
Cardio protective activity of Passiflora foetida extract and silver nanoparticles in doxorubicin induced cardiac disease in rats
Medicinal plants have been observed to possess numerous activities with regard to cardiovascular system viz. antiplatelet, hypolipidemic, anti-inflammatory, hypoglycemic and hypotensive actions. For cardiovascular dise...