Tuesday, May 20, 2008
Student Union Building, Upper (Queensborough Community College)
555

Validation of Analytical Procedures for the Determination of Some Pharmaceutical Products

Hilmi Ibar and Özlem Bayram Basdag. Trakya University, Edirne, Turkey

The Analytical methods for the determination of some pharmaceutical products have been developed and validated. The analytical methods used in the drug industry must be accurate, precise, reliable and repetable. We investigated number of analytical procedures in order to ensure ones that would be suitable for application as a quality control procedure for studied drugs. For this purposes 3 different studies are performed:

1. Analytical method was developed for determination of Methylen Chloride film used for the coating of tablets which contains Sildenafil Citrate active material.

2. Analytical method for determination of products which contains Valaciclovire HCl active material.

3. Analytical method for determination of Thiocochicoside drug and its preservative materials, Methyl and Ethyl paraben.

Validation of the developed method is done according to the “European Agency for the Evaluation of Medical Products”, those includes: Accuracy of the Method, Precision, Specifity, Range and Linearity.

Evaluation of the procedures demonstrated that the procedures are reliable and are suitable for its intended purposes. From the data's obtained it was seen that amount of reagents used for performing analysis is 8-10 times lower, amount of sample used for analysis 6-12 times, and labor is 1-3 times lower than in used routine procedures.