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Analytical Development ::

Analytical Development department is equipped with modern instrumentation facilities viz.

HPLC :

The HPLC systems (17 in no.) are used for identifying and estimating the purity of all types of chemicals such as bulk drugs, excipients, intermediates and formulations. They are also used for assaying the active ingredients in various dosage forms and in assaying the drugs in biological fluids such as plasma, serum, urine and tissues for bioavailability and/or bio-equivalence studies of drugs in formulations.

The following are various HPLC systems available:

Biocompatible gradient HPLC system
High pressure gradient HPLC systems
Isocratic HPLC systems
Besides U.V. detectors these systems are equipped with advanced detectors like; ECD, Conductivity detector, Photo Diode Array detector, Refractive index detector, Fluorescence detector etc.

GC & GCHS :

Capillary Gas Chromatograph with FID detector and Head-Space Gas chromatograph with FID and EC detectors available at the department are high resolving and sensitive instruments useful for the analysis of volatile compounds. GC-HS is used for the analysis of trace quantities of residual solvents in formulations. Residual solvents may be toxic and there presence may alter the physico-chemical properties especially dissolution of the formulation. So the determination of residual solvents and their limit in the dosage forms by GCHS are very important.

FT-NMR (400 MHZ) :

Bruker FT-NMR Spectrometer is versatile instrument widely used in research for three dimensional structure elucidation of organic compounds. It is also used for the identification of starting raw materials, intermediates and finished products in the synthesis of many compounds.

Qualitative and quantitative monitoring of reactions is possible, also useful for finding out the structures of lead compounds in natural products isolated from plants, microbial broths and biological fluids and for studying structure activity relationship of new molecular entities.

Mass Spectrometers (With Latest ION Trap Technology) :

There are 2 Mass Spectrometers available to scientist in this department. The first instrument with Electron impact/chemical ionisation modes can be coupled to capillary gas chromatography. The second instrument with Atmospheric pressure ionisation source can be coupled to HPLC.

The coupling techniques will ensure the separation and identification of ingredients in a mixture.

Mass Spectrometers (MS) with data systems (DS) are useful in identification, estimation and structure elucidation of organic molecules. Systems are useful to get molecular weight, molecular formula, fragmentation pattern and structures of new molecules. Since the Mass Spectrometer signal is highly specific, throughout analysis of trace quantities of drugs in plasma, serum and urine samples for bioavailability and/or bioequivalence of formulations increases by many fold. Structures of degradation products in formulations of long term storage or accelerated stability storage determined using NMR and MS can be used to predict their toxicity.

Laser Diffraction Particle Size Analyzer :

Particle size analyzer is used for pharmaceutical formulations research and development purpose. The determination of size of particles of raw materials, bulk drugs, excipients and pharmaceutical formulations is very important to decide the dissolution and then absorption of the drug formulation in-vivo. The rate of dissolution is inversely proportional to the particle size. So particle size of the drugs and excipients plays very important role in the dissolution and absorption. Counting and sizing particulate matter in the perenterals such as injections, infusions and liquid pharmaceutical aids and its control is very important for intravenous and muscular injections to avoid adverse reactions by the human systems.

Elemental Analyser :

Elemental analyser is used to detect and quantify the percentage of C, H, N, O/S and other elements present in the molecule. This instrument is useful to confirm / characterize structures of known / new molecules and also used to characterize impurities from bulk drugs, degradation products from formulations and metabolites for pharmacokinetic studies.

2D Page Apparatus :

2D PAGE is a two dimensional polyacrylamide gel electrophoresis used to separate a complex mixture of proteins and peptides from biological samples. Identification and estimation of trace protein analytes of interest is also possible.

Electrophoresis is a very useful separation technique, which involves the separation of charged molecules on the basis of their movement under the influence of an applied electric field. This provides powerful means of separating biocolloids such as proteins, polysaccharides and nucleic acids, as well as characterization of their compounds.

Other equipment :