STABILITY INDICATING HPTLC METHOD DEVELOPMENT AND VALIDATION FOR CINACALCET HYDROCHLORIDE API
About Authors:
Gautam Kumar
SRM college of pharmacy, SRM University
Chennai 600 033.
gautamsinghsrmcp@gmail.com
Abstract
The aim of the present work to develop validated RP-HPLC method which determines stress stability and concentration of Cinacalcet hydrochloride in synthetic mixture as per ICH guidelines. Separation was performed using Camag Linomat V semi Automated sample applicator with TLC Scanner III. Stationary Phase consisting of TLC plates (Merck) pre coated with silica gel 60F254 on Aluminum Sheets was used. Mobile phase comprising of Methanol: Water: Glacial acetic acid (5:5:0.2v/v/v) was used. All the system suitability parameter was found within the range. The method was extensively validated for specificity, linearity, accuracy, precision, recovery, limit of quantitation and detection. The Cinacalcet hydrochloride was found to be highly labile to alkaline and acid hydrolysis compared to oxidation. Chromatographic peak purity results indicated the absence of co-eluting peaks with the main peak of Cinacalcet, which demonstrated the specificity of assay method for estimation of Cinacalcet in presence of degradation products. The proposed method can be used for routine analysis of Cinacalcet in quality control laboratories.
HLL Biotech Limited (HBL) is a 100% subsidiary of HLL Lifecare Limited, a Mini Ratna Schedule B Central Public Sector Enterprise under the Ministry of Health & Family Welfare. HBL is setting up a vaccine complex at Chengalpett, Chennai for manufacturing of Bacterial and Viral Vaccines & developing a strong R&D base for vaccine technologies within the country.
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Pharmacovigilance is the pharmacological sciences relating to the detection, assessment, understanding and prevention of adverse effects, particularly long term and short term side effects of the therapeutic drugs, devices and biologics. Setting up of stringent laws by regulatory bodies (e.g. US-FDA, DCGI, EMEA etc.) has led to the adoption of a systematic Pharmacovigilance framework worldwide.
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