Introduction and definition:
The term analysis is very well known and is having vital importance in almost all fields. As we know very well that life is the only importance for all living beings and the living beings do anything for their life. To lead a happy and healthy life, quality of the products that are being consumed and used is most important aspect. The process of testing the quality of any substance is termed as analysis of that substance. In every area of life, whatever we use or consume, this analysis is of vital importance as all those will affect the health of any living being.
Pharmaceutical products are meant to improve/restore the health of the recipient. Hence, examining pharmaceutical products is very much important before we consume them. Analysis process of a pharmaceutical product involves a series of processes which help in identification, determination, quantitation and purification of a pharmaceutical product. Analysis is the term derived from Greek words ‘ana’ means ‘up’ or ‘throughout’ or ‘thoroughly’ and ‘lysis’ which means ‘a loosening’ or ‘unravel’. Hence, analysis can be defined as the process in which all details of a compound like its identification, composition (atomic, molecular and substance composition), structure, properties, behaviour etc. are unravelled along with the determination, quantitation and purification of a product. Pharmaceutical analysis means the analysis of a pharmaceutical product. i.e., pharmaceutical analysis can be defined as a process in which the identification, composition, structure, properties, behaviour, determination, quantitation and purification of a drug/pharmaceutical product is ravelled. Pharmaceutical analysis deals with drugs as both pharmaceutical products/formulations and bulk drug substances.
Scope of Pharmaceutical Analysis:
The role of pharmaceutical products is very important in human health and hence, pharmaceutical analysis is vital in pharmaceutical industries. The quality of a pharmaceutical product is the output of a series of analyses that start from the analysis of starting/raw material, in-process during the conversion stage which is extended till the finished product. For a pharmaceutical product to enter into market, in every stage of its manufacturing, its quality should be ensured which will assure the safety of the product. The standard protocols for manufacturing and quality of drugs and other pharmaceutical products are prescribed by Pharmacopoeia. Any drug or pharmaceutical product that deviates in quality aspects prescribed by Pharmacopoeia are referred as sub-standard.
The quality of drugs/pharmaceutical products should meet the prescribed standards related to safety, potency and efficacy. The pharmaceutical analysis gives information about the following majorly.
- Drug substance analysis:
Drug substance analysis is concerned with the analysis of active pharmaceutical ingredient in a pharmaceutical/drug formulation and is one of the important aspects in pharmaceutical analysis. This process involves a range of techniques which include:
- Spectroscopic methods like ultraviolet (UV) spectroscopy, infrared (IR) spectroscopy, nuclear magnetic resonance (NMR) spectroscopy, mass spectroscopy etc. which helps in identification and quantification of pharmaceutical ingredient and any impurities present.
- Chromatographic techniques like high performance liquid chromatography (HPLC), gas chromatography (GC), ion chromatography (IC) etc. which are used to separate and quantify the components of the product under study.
- Thermal analytical techniques include differential scanning calorimetry (DSC) and thermogravimetric analysis (TGA) that are used to determine the thermal behaviour and the stability of the drug substance.
- Drug product analysis:
Drug product analysis concerns with the analysis of the finished product which includes tablets, capsules, injections and other dosage forms and is another important area of pharmaceutical analysis. This analysis also involves:
- Spectroscopic techniques like UV spectroscopy, IR spectroscopy etc.
- Chromatographic techniques like HPLC, GC etc.
- Dissolution testing which helps in determining the rate of drug release from a dosage form.
- Method development and method validation:
This is the process of developing/selecting and optimizing a suitable analytical technique for a specific product/sample. The parameters optimised to obtain the required information include composition of mobile phase, type of column, wavelength detection etc. This method is designed/used to ensure the obtained results across different laboratories and instruments are accurate, reliable and consistent. Method development is selecting/developing a suitable analytical method/technique and its optimisation whereas the method validation is the process of demonstrating that the selected/developed analytical technique is accurate, precise and reliable.
- Quality control and quality assurance:
Controlling and assuring the quality of a drug/pharmaceutical product is very crucial aspect in pharmaceutical analysis. The main intention of using analytical techniques is to ensure that the drugs/pharmaceutical products meet the required quality standards. Quality control includes monitoring the raw materials, production process and finished products. Whereas quality assurance implements a system that ensures the quality of a product of interest.
For controlling and assuring the quality of a drug/pharmaceutical product a range of analytical techniques are used such as:
- Spectroscopic methods and chromatographic techniques like HPLC, GC for monitoring the levels of active ingredients, impurities and degradation products present in drugs/pharmaceutical products.
- Dissolution techniques are used to test and determine the rate of drug release/release of active ingredient from the drug product/pharmaceutical product.
- Microbiological testing to ensure that the drug product/pharmaceutical product is free from any kind of microorganisms.
- Stability testing is done to ensure the stability of the drug product/pharmaceutical product over time and to determine the shelf life of the same.
- Regulatory compliance:
Any drug/pharmaceutical product should compile with the standards set by regulatory bodies such as FDA (Food and Drug Administration), EMA (European Medical Agency) etc. which are present all around the world before entering into the market. These regulatory bodies set strict rules regarding the safety, efficacy and the quality of a drug/pharmaceutical product. Compliance with the rules set by these regulatory bodies is critical for ensuring the safety and effectiveness of the drugs for the use by patients. After getting approval from these regulatory bodies only any drug/pharmaceutical product will be marketed. Regulatory compliance of a drug/pharmaceutical product is also done by using analytical techniques which must be validated give accurate and reliable results.
For career in Pharmaceutical Analysis, certain level of education is required.
- A student must possess knowledge in the areas of biology, chemistry, physics and mathematics to become a Pharmaceutical Analyst.
- The candidate must possess a degree in Pharmaceutical Analysis, Pharmacology, Chemistry or any related subject to be the ideal candidate for the position of Pharmaceutical Analyst.
The field of Pharmaceutical Analysis has a wide range of applications like:
- Classifying a compound according to its chemical properties.
- Analyzing mixtures for compounds (composition of a compound).
- For separating components from mixtures.
- For purification, identification and characterization of drugs/pharmaceutical products.
- Many companies are running a separate analytical R&D department as it has huge implications on the results of analysis and detection/identification of new compound.
- We should keep in mind that whatever the compound has been discovered or formulated, unless it is analyzed and validated, it is not valid.