JAWAHARLAL NEHRU TECHNOLOGICAL UNIVERSITY HYDERABAD

Course Objective

The principles and procedures for the determination of various pharmaceutical bulk

drugs and their formulations belonging to different categories are discussed in detail. The applications of the important reagents like MBTH, FC, PDAB etc. in the determination of the pharmaceuticals are also discussed.

Course Outcome

The quantitative determination of various organic compounds is clearly understood.

The spectral analysis, dissolution parameters and microbial assays are also learned.

UNIT - I

Principles and procedures involved in the determination of the official compounds in IP with the following analytical techniques A. Non-aqueous C. Complexometric B. Oxidation-reduction D. Diazotization methods E. Neutralization F. Acid – Base

UNIT - II

A detailed study of the principles and procedures involved in the quantitative determination of the following organic functional groups A. Amines C. Carbonyl compounds B. Esters D. Hydroxy and carboxyl E. Amino Acids

UNIT - III

• a. Reference Standards: Types, preparation methods and uses.
• b. Principles and procedures involved in using the following reagents in the determination of pharmaceutical dosage forms official in IP
• a. MBTH (3-methyl-2-benzothiazolone hydrazone)
• b. F.C. Reagent (Folin-Ciocalteu)
• c. PDAB (para-Dimethyl Amino Benzaldehyde)
• d. 2, 3, 5 - triPhenyltetrazolium salt
• e. 2,6 di -ChloroquinoneChlorimide
• f. N - (1-naphthyl) ethylenediaminedihydrochloride (B.M. Reagent)
• g. Carr – Price Reagent
• h. 2,4 - DNP

UNIT - IV

• a. Analysis of Excipients: Tests related to excipients such as bulk density, tapped density, particle size distribution, pH, moisture content, viscosity (dynamic), loss on drying, ash content, conductivity.
• b. Excipients of interest: Disintegrating agents, binders, emulsifiers, viscosity modifiers and preservatives including preservative challenge test.

UNIT - V

• a. Dissolution Tests: Types of Dissolution apparatus, dissolution test requirements for immediate release, delayed release, extended release dosage forms, coated, uncoated, enteric coated, gelatin capsules etc. R19 M.PHARM PHARMACEUTICAL ANALYSIS
• b. Microbiological assays and Biological tests: Antimicrobial effectiveness testing, microbial limit tests, sterility test. Antibiotics-microbial assays, bacterial endotoxins test.

TEXT BOOKS:

• 1. Pharmaceutical Chemistry by Becket and Stanlake
• 2. Pharmaceutical Analysis by Higuchi, Bechmman and Hassan
• 3. Instrumental Methods of Chemical Analysis By B.K. Sharma
• 4. A Text Book of Pharmaceutical Analysis by Kennenth A. Conners
• 5. Organic spectroscopy by Y.R Sharma Principles of Instrumental Analysis - Doglas A Skoog, F. James Holler, Timothy A. Nieman, 5th edition, Eastern press, Bangalore, 1998.
• 6. Instrumental methods of analysis – Willards, 7th edition, CBS publishers.

REFERENCES:

• 1. Remington’s Pharmaceutical Sciences by Alfonso and Gennaro
• 2. Quantitative Analysis of Drugs in Pharmaceutical Formulations by P.D. Sethi
• 3. Indian Pharmacopoeia 2010
• 4. Journals (Indian Drugs, IJPS etc.) R19 M.PHARM PHARMACEUTICAL ANALYSIS M.Pharm I Year I Sem (Pharmaceutical Analysis)