Chennai

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.

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.

About Author:
Gautam Kumar
SRM college of pharmacy,SRM University
Chennai 600 033.
gautamsinghsrmcp@gmail.com

Abstract
The aim of the present work is to develop validated HPTLC method which determines stress stability and concentration of Quetiapine and its formulation as per ICH guidelines. Separation was performed using Camag Linomat V semi Automated sample applicator with TLC Scanner III. HPTLC analytical measurement and separation were performed using Stationary Phase consisting of TLC plates (Merck) pre coated with silica gel 60F254 on Aluminum Sheets was used. Mobile phase comprising of Methanol: Toluene (7:3 v/v) was used. All the system suitability parameter was found within the range. Area under curve was measured at 235nm. The method was extensively validated for specificity, linearity, accuracy, precision, recovery, limit of quantitation and detection. The proposed method can be used for routine analysis of Quetiapine in quality control laboratories.

About Authors:
Ashokkumar.m*, M.Senthil kumar, Dinesh, Jenish, Marshel, Hariharan
Annai veilankanni’s college of pharmacy
Saidapet, Chennai-600015, Tamilnadu
*mgashokkumar123@gmail.com

ABSTRACT
Atypical antipsychotic Quetiapine was used for the treatment of schizophrenia is a severe illness with substantial effects on individual and social functioning, Quetiapine and its active metabolite N-desalkyl-Quetiapine have affinities to dopaminergic D1-and D2receptors,5-HT2 receptors. To design of immediate release dosage form of quetiapine fumarate that will help in releasing drug with short period of time. The quetiapine fumarate tablets were successfully prepared by direct compression method. The physiochemical evaluation results for the powdered material of all trials pass the official limits in angle of repose, compressibility index and drug content. In the 9 trials, the optimized formulation was F3 trial which releases the quetiapine fumarate  immediately within an hour.