May 2011

Marion Biotech strongly believes in an integrated approach to healthcare. It is also engaged in extensive Research & Development of unique Herbal products. At Marion Biotech, we set Stringent Standards of Quality, Safety and Efficacy for all the Products that we manufacture.

One of India's most respected Companies, Shree Baidyanath Ayurved Bhawan (p) Ltd. (Kolkata), popularly known as Baidyanath, is the acknowledged leader of Ayurvedic know-how. Established in 1917, the Company has played a pioneering role in re-establishing ancient knowledge with modern research and manufacturing techniques.

About Author: Kale Vishal Bibhishan
Department Of Pharmacy, School Of Chemical Engineering and Bio-Technology
SASTRA UNIVERSITY, Thanjavur-613402, Tamil Nadu, INDIA

Reference ID: PHARMATUTOR-ART-1064

Abstract
Pre-clinical phase is a laboratory test of a new drug on animal subjects, conducted together evidence justifying a clinical trial. For those drugs which are in clinical phase, method development requires various pre-clinical bioanalytical support parameters. Bioanalytical support plays a pivotal role in answering a series of questions concerning the toxicity, pharmacokinetic parameters, safety assessment, formulation optimization .Once method development process was initiated one should know the different techniques of sampling, handling, sample preparation methods that are suitable and problems in it. After sample preparation, suitable analytical techniques have to be selected for method development.  The developed method now have to be validated, for this, Initially “Analytical Instrument Qualification” has to be performed which includes four main phases- Design qualification, Installation qualification, Operational qualification and Performance qualification. Method is said to be validated when all considered validation parameters like linearity, specificity, selectivity etc are within the limits. Thus the method is developed and validated for a drug in preclinical phase using analytical technique of suitable sensitivity and selectivity.

About Author: V. Ranjith Kumar*, Chintalapti Sujitha
* Department of Pharmaceutical Analysis,
Priyadarshini college of Pharmaceutical Sciences,
Chowdaryguda, Narapalli, Ghatkesar (Mo),
RR-District-501301. AP-INDIA.

Reference ID: PHARMATUTOR-ART-1062

Abstract
A simple, accurate, cost effective and reproducible spectrophotometric method has been developed for the estimation of Sitagliptine in bulk and pharmaceutical dosage form. Visible spectrophotometric method, which is based on measurement of absorption at maximum wavelength 540 nm. The accuracy of the methods was assessed by recovery studies and was found to be ranging from 99.5-101.5 .The developed method was validated with respect to linearity, accuracy (recovery), precision and specificity. Beers law was obeyed in the concentration range of 25-125 µg/ml having line equation y = 0.026x + 0.016 with correlation coefficient of 0.999. Results of the analysis were validated statistically and by recovery study.