The outline of Pharmaceutical Analysis

( For Students of Pharmacy)

1 . Identifying Information

Course Code : 050249

Course Title : Pharmaceutical Analysis

College : College of Pharmacy

Status: Specialized Course

Course : 72

Credit Point Value : 4.0

Prerequisites : Compulsory Course

Semester : the 7th semaster

2 . Introduction of Pharmaceutical Analysis

Pharmaceutical analysis is one of the most important course to the students of College of Pharmacy, and a specialized course for the students of Pharmacy. It is one of the most important fields in pharmaceutical science.

Pharmaceutical analysis is a comprehensive applied analytical science that uses the classical and modem analytical measures to study the property of drugs , to establish the drugs standards , and to control the quality of drugs and also to be applied to drug discovery, pharmacology , toxicology , pharrnacodynamics, metabolism, pharmacokinetics, bioavailability requirements , formulation development ; and drug use including therapeutic drug monitoring (TDM ) , drug abuse monitoring , overdosage monitoring , analytical toxicology and drugs in sport ( doping control ) .

Pharmaceutical analysis is a science not only establishing and developing methods of quality control of drugs , but also supplying necessary preparatory and service for the researchers and developments of other fields in the curriculum , such as Pharmaceutical Engineering .

3. Objectives

After study this course, the students are expected to learn:

(1) To set up a conception in students thought that the qualities of drugs are the most important. Make sure that we should strictly control the qualities of drugs in all sectors of productions, supplies and clinical applications.

(2) Correct use of quality standard of drugs. Students will be familiar with selecting analytical methods according to the chemical structure, characterization and state. Practically grasp the principle and methods of identification, impurity detection and assay of drugs.

(3) To develop essentially practical skills, and the usage of modern analytical apparatus.

Chapter 1 The Study of the Quality Standards of Drugs and the overview of Pharmacopeias

【Teaching Contents】

1. The purpose of the study of the quality standards of drugs

2. The contents of the study of the quality standards of drugs

3. The classification of the quality standards of drugs

4. The Contents of Ch.P.

5. The overview of main foreign pharmacopoeia ( USP . BP ) .

【Basic Requirements】

1. To master the contents of the study of the quality standards of drugs

2 . To mastar the content of ChP.

3 . To be familiar with the main foreign pharmacopoeia.

Chapter2 The identification test of drugs

【Teaching Contents】

1. The items and the methods of identification test.

2. Analytical method validation

【Basic requirements】

1. To master the validation characteristics for analytical procedures .

2. To be familiar with the validation characteristics for bioanalytical procedures.

Chapter 3 The impurity tests of drugs

【Teaching Contents】

1. Impurities in drugs and limit of impurity (the purity of drug , impurities and their sources , calculation of Limit are all included ) .

2. Limit tests for chlorides, sulfates, irons, heavy metals and arsenic.

3. The application of chemical analysis to limit tests of specific impurities.

【Basic requirements】

1. To master the resources and classification of impurities,

2. To master the calculation of limit for impurities,

3. To master the principle, actions of reagents used, Interferences and elimination methods of Limit tests for chloride, sulfate, iron, heavy metals and arsenic.

4. To be familiar with the application of chemical analysis to Limit test for specific impurities.

Chapter 4 Method and validation for Assay

【Teaching Contents】

1. The pretreatment of samples(Organic destruction, Non- organic destruction).

2. The validation of analysis method of drug quality standards.

【Basic requirements】

1. To be familiar with the method of the pretreatment of the organic destruction and Non- organic destruction

2. To master the method of titration, UV, HPLC and GC.

3. To master the validation of analysis method.

Chapter 6 The Analysis for Nonsteroidal Anti-inflammatory Drugs

【Teaching Contents】

1. The structure and properties of Nonsteroidal anti-inflammatory drugs.

2. The identification tests.

3. The test of special impurities.

4. The assay of Nonsteroidal anti-inflammatory drugs.

【Basic requirements】

1. To be familiar with the structure and properties

2. To master the methods of identification, assay and impurities test of Nonsteroidal anti-inflammatory drugs.

Chapter 7 The Analysis for Epinephrine Drugs

【Teaching Contents】

1. The structure and properties of epinephrine drugs.

2. The identification tests.

3. The test of special impurities.

4. The assay of epinephrine drugs.

【Basic requirements】

1. To be familiar with the structure and properties

2. To master the methods of identification, assay and impurities test of epinephrine drugs.

Chapter 9 The Analysis for Dihydropyridine Drugs

【Teaching Contents】

1. The structure and properties of dihydropyridine drugs.

2. The identification tests.

3. The test of special impurities.

4. The assay of dihydropyridine drugs.

【Basic requirements】

1. To be familiar with the structure and properties

2. To master the methods of identification, assay and impurities test of dihydropyridine drugs.

Chapter 10 The Analysis for Sedative-hypnotic Drugs

【Teaching Contents】

1. The structure and properties of sedative-hypnotic drugs.

2. The identification tests.

3. The test of special impurities.

4. The assay of sedative-hypnotic drugs.

【Basic requirements】

1. To be familiar with the structure and properties

2. To master the methods of identification, assay and impurities test of sedative-hypnotic drugs.

Chapter 11 The Analysis for Phenothiazine Antipsychotic Drugs

【Teaching Contents】

1. The structure and properties of phenothiazine antipsychotic drugs.

2. The identification tests.

3. The test of special impurities.

4. The assay of phenothiazine antipsychotic drugs.

【Basic requirements】

1. To be familiar with the structure and properties

2. To master the methods of identification, assay and impurities test of phenothiazine antipsychotic drugs.

Chapter 13 The Analysis for Anticholinergic Drugs

【Teaching Contents】

1. The structure and properties of Anticholinergic Drugs.

2. The identification tests.

3. The test of special impurities.

4. The assay of Anticholinergic Drugs.

【Basic requirements】

1. To be familiar with the structure and properties

2. To master the methods of identification, assay and impurities test of Anticholinergic Drugs.

Chapter 14 The Analysis for Vitamins

【Teaching Contents】

1. The structure and properties of Vitamins.

2. The identification tests.

3. The test of special impurities.

4. The assay of Vitamins.

【Basic requirements】

1. To be familiar with the structure and properties

2. To master the methods of identification, assay and impurities test of Vitamins.

Chapter 15 The Analysis for Steroid Hormones

【Teaching Contents】

1. The structure and properties of steroid hormones.

2. The identification tests.

3. The test of special impurities.

4. The assay of steroid hormones.

【Basic requirements】

1. To be familiar with the structure and properties

2. To master the methods of identification, assay and impurities test of steroid hormones.

Chapter 16 The Analysis for Antibiotics

【Teaching Contents】

1. The structure and properties of antibiotics.

2. The identification tests.

3. The test of special impurities.

4. The assay of steroid antibiotics.

【Basic requirements】

1. To be familiar with the structure and properties

2. To master the methods of identification, assay and impurities test of antibiotics.