One of the significant challenges before the pharmaceutical industries today is developing ways for increasing productivity and subsequently decreasing costs of their new entities that enhance human health. Analytical testing is one of the crucial parameters employed in improving both the safety and quality of these pharmaceutical entities. They provide information about various chemical and physical parameters of a pharmaceutical drug candidate under analysis. Both the qualitative and quantitative results derived from such analytical testing helps in controlling and confirming the properties of the raw materials that go into the product development, the active and inactive ingredients involved, and that of the processing of the finished products.
Importance of the analytical method development –
The protocol for the method development provides the following essential information to the analyst which enables him to estimate or quantitate a particular drug –
The required data for developing a solution to the given analytical problem inclusive of sensitivity, accuracy, range of analysis, precision, and validation or evaluation.
What are the criteria required for method development?
Method development and validation are the undeniable aspects of the pharmaceutical industries. The basis of product determination for the evaluation of its quality and quantity highly relies on the approach of drug analysis. In most cases, it was observed that there is a time lag between the date of release of the drug to its final inclusion in pharmacopoeias. This is due to the potent uncertainties observed in broader applicability of these pharmaceutical drug products, reporting of newer toxicological effects, and identification of the cases related to the patient resistance, and higher competency with the introduction of new generics in the market.
It may sometimes so happen that a new drug or the drug combination generated may not possess an official identity in any of the pharmacopoeias. There may be a lack of the proper analytical procedure in the market on account of patent regulations. Sometimes, the analytical methods may not be available or may lack the efficiency to detect the formulation excipients. Analytical methods for determining the drug developed in conjunction with some other drug available in the market may not be available.
Steps involved in the process of method development –
Right from the beginning of the drug discovery and development process, the personnel involved should work on documenting the results generated. Irrespective of the documentation, the following steps are an integral part of any method development process –
Characterization of the analyte standard –
Here, the R&D personnel characterizes all the required information about the analyte concerning its physicochemical properties.
Method Requirements –
The analytical method development requires setting linearity, detection limit, range, selectivity, accuracy, and precision for the method being developed.
Literature search –
For the production of pharmaceutical entities and studying their physicochemical properties, literature such as books, periodicals, journals, and regulatory agency compendia are thoroughly reviewed.
Selection of an optimum method –
With the information available in the books and prints mentioned under literature search, an optimum analytical method is developed. Whenever and wherever necessary, these methods are thoroughly verified before putting it to practical use.