Arulmigu Kalasalingam College of Pharmacy

Pharmaceutical Analysis

About the Department:

The Department of Pharmaceutical Analysis has the state of art facilities for qualitative and quantitative analysis of drugs and pharmaceuticals. Pharmaceutical analysis includes a series of process for identification, determination, quantification and purification of substance, separation of the components and determination of structures of chemical compounds. It supports pharmaceutical product development from early development to manufacture.

The principal focus of the department is development and application of analytical methods and techniques relevant to pharmaceutical sciences. The Pharmaceutical Analysis laboratory is closely associated with other departments of the Institution.

The department is well equipped with modern analytical instruments and other facilities and is involves in various research activities like development and validation of novel analytical methods by using HPLC & UV / Vis spectrophotometer.

The department is provided with eminent faculty members. The faculty members have been attending various seminars, workshops and conferences at National and International levels. They have also been presenting and publishing their research findings in National/International journals.

Core competencies:

The department involved in the development and evaluation of following products

  1. Immediate release dosage forms
  2. Sustained release dosage forms
  3. Nanopharmaceuticals
  4. Transdermal drug delivery systems
  5. Multi-particulate drug delivery systems
  6. Ocular drug delivery systems
  7. Semisolid dosage forms

Infrastructure

S. No

Instrument

1

Ultra Fast Performance Liquid Chromatography with UV-Vis detector

2

High Performance liquid chromatography with variable wavelength detector

3

FT-IR

4

UV Visible spectrophotometer (Single beam)

5

UV Visible spectrophotometer (Double beam)

6

Flame Photometer

7

Karl Fischer Titrator

8

Fluorimeter

9

Nepheloturbidimeter

10

pH Meter

11

Rotary Vacuum Evaporator

Services Offered:

The activities of the department other than the regular conduct of theory and practical classes for under graduate and post graduate courses include the following:

Analytical method development:

Analytical methods can be developed for raw materials and dosage forms for which no compendal methods are available. Development of newer analytical methods for the estimation of food constituents and contaminants by LCMS and Atomic absorption spectroscopy.

Analytical method validation:

Method validation (to confirm that the particular method is suitable for it use) can be performed for non-compendial methods- Linearity / Range, Precision, Repeatability, Ruggedness, Accuracy, Specificity, Detection / Quantitation Limit, Robustness.

Evaluation of trial dosage forms:

Identification, assay, content uniformity, related substances, water content and physical parameters can be analysed for tablets and capsules (IR, MR, ER) ,Liquids and Injectable

Analysis of marketed samples

Identification, assay, content uniformity, related substances, water content and physical parameters can be analysed for tablets and capsules (IR, MR, ER), Liquids and Injectables.

Analysis of active pharmaceutical ingredients:

Active pharmaceutical ingredient can be tested as per compendial monographs or as per In-house methods.

Identification of new synthetic compounds by IR spectroscopy:

IR spectra can be taken for identification of functional groups for new synthetic compounds.

Release and in-process testing:

Analysis of in-process samples like granules, blend etc and finished products (tablets, capsules etc) for Assay, Related substances and Water content.

Stability testing and Stability data trending:

Analysis of stability samples for Assay, Related substances and Water content and preparation of stability report.

Analytical support for pharmaceutics department:

Analysis of trial samples of pharmaceutics department-Assay, Related substances, Content uniformity. Release rate etc.

Reference standard analysis:

Analysis of reference standard for potency

Analysis of spiked samples for invitro studies:

HPLC quantification-Spiked plasma samples can be analysed using HPLC.

Water content:

Analysis of water content of raw materials, powder, granules and dosage forms using Karl Fischer titrimetry.

Clinical analysis:

Clinical analysis of metals in biological fluids and tissues such as whole blood, plasma, urine, saliva, in some pharmaceutical manufacturing processes and analyzing water for its metal content by Atomic absorption spectrometry.

Determination of crystallinity:

Identification of crystalline material, polymorphic forms (“fingerprints” ),distinguishing between amorphous and crystalline material and quantification of the percent crystallinity of a sample by X-ray diffraction.

Topographical, morphological and compositional analysis:

High-resolution images of shapes of objects (SEI) and show spatial variations in chemical compositions can be done by Scanning Electron Microscope