The drugs that are being introduced in the market are increasing every year. Either new entities or structurally modifications of the existing molecules are developed. A time lag exists for all the drugs, a time of introduction into the market to the date of its addition in pharmacopoeias. This is for the possible doubts in the continuous and larger usage of these drugs, which may be reported for new toxicities which may result in their withdrawal from the market and development of resistance and/or introduction of a better drug by competitors. Under these conditions, the monographs may not be available in the pharmacopoeia which becomes necessary, therefore, to develop newer analytical methods for such drugs.
Thus the various reasons for the requirement for the development of newer analytical methods for a drug are as follows:
- The drug or drug combination may not be official in any pharmacopoeia - An analytical procedure may not be available in the literature due to patent regulations
- Methods may not be available for the drug in a formulation due to the intervention of formulation excipients or impurities
- Analytical methods for a drug in combination may be available but the existing analytical procedures may require expensive reagents and solvents.