Table of Contents
Definition and scope of pharmaceutical analysis
Pharmaceutical analysis is a branch of chemistry which is a involves the application of analytical procedures to ensure the purity, quality and safety of pharmaceutical products. It involves qualitative and quantitative analysis that consist of series of procedures for identification, determination, quantitation and purification.
The measure application of pharmaceutical analysis includes:
• identification of chemical category of compounds.
• determination of compounds in mixture.
• separation of the components from a mixture.
• isolation, purification and structural identification of compounds.
Pharmaceutical analysis and quality control is vital in pharmaceutical industries as the pharmaceuticals have an important role in human health.
Quality of drugs is vital and those which deviate in quality aspects are referred as a sub-standard. The quality of drug (product) is an output of series of analysis starting from the raw materials, in process during the conversion stage and extend till finished product. The quality of the product should be ensure in every stage of manufacturing and quality of drugs should be in accordance with the standard protocols prescribed by pharmacopoeia. Quality of drugs should meet the standards related to safety, potency and efficiency. Hence all these parameter of quality are evaluated by various quality control methods.
Purity of product
When a chemical is free from impurities or contaminants, it is said to be chemically pure. It is a extremely difficult to achieve 100% of chemical purity during manufacturing process, however with special care in production process, achieving the optimum purity is possible.
The impurities present in such chemicals may interior with the stability and biologically activity of the drugs. Once should ensure the purity of the chemicals before selection and use. Thus there are certain prescribed standard available to decided the purity of chemicals. These standards are prescribed by official monographs in the pharmacopoeia. Definition and scope of pharmaceutical analysis read carefully.
Different techniques of pharmaceutical analysis
There are various techniques of pharmaceutical analysis which can be divided into two major categories: first quality analysis and second quantitative analysis.
1. Qualitative analysis
These kind of analysis confirm the presence or absence of a compound in sample to be analyzed. Example:-color reaction test, limit test, melting or boiling point determination and precipitate formation. With the help of qualitative analysis, we can easily identify which compound is present in any drug. Definition and scope of pharmaceutical analysis read carefully.
2. Quantitative analysis
This category of analysis involves the quantitative determination of compounds in the sample this type of analysis can be further subdivided into following classes:
1. Chemical methods
2. Physicochemical methods or Instrumental methods
3. Microbiological methods
4. Biological methods
1. Chemical methods
In chemical methods, measurement of volume of solution is taken as parameter for assay. The volume of occurrence strength of a solution that is required to react completely with the substance to be analyzed is measured. The quantity of analyte is determined from the volume of solution by calculation. The solution or reagent is called as torrent and the analyte to be analyzed in termed as titrate.
The ideal characteristic in this method to be considered are that, the regents selected should react rapidly with the analyte, the reaction must be complete and there should be some method of detection to detect the end of reaction.
2. Instrumental methods
These methods involves the usage of instruments to measure the physical or physicochemical property of company to be adjusted thus let to quantitation of the compound. It is depending on the physical property of the compound various instruments have been used for the measurement. Definition and scope of pharmaceutical analysis read carefully.
3. Biological methods
Biological assays are carried out to observe the biological effect of the drugs on some type of living matter. These is also called as bioassays. These are recommended when the Chemical or physical methods are not capable to estimate the potency of drug. Bioassays involves the measurements of various parameters including weight of tissues of organ, weigh of organs, blood parameters such as blood glucose, chocolate, urea, enzyme concentration, etc. Definition and scope of pharmaceutical analysis read carefully.