Drug development accuracy analysis

We have developed chemiluminescent immunoenzymatic assays for (3-ago-nist drugs in the 96-well-microtiter-plate format. Such competitive assays have been used for determination of clenbuterol and of the overall content of p-agonist drugs in the sample. They matched the standard requirements of precision and accuracy, and were more sensitive compared to the conventional colorimetric methods. Moreover, CL detection was very rapid, making these assays suitable for screening analysis. 

The ability to provide accurate and reliable data is central to the role of analytical chemists, not only in areas like the development and manufacture of drugs, food control or drinking water analysis, but also in the field of environmental chemistry, where there is an increasing need for certified laboratories (ISO 9000 standards). The quality of analytical data is a key factor in successfully identifying and monitoring contamination of environmental compartments. In this context, a large collection of methods applied to the routine analysis of prime environmental pollutants has been developed and validated, and adapted in nationally or internationally harmonised protocols (DIN, EPA). Information on method performance generally provides data on specificity, accuracy, precision (repeatability and reproducibility), limit of detection, sensitivity, applicability and practicability, as appropriate. 

Shim et al. [59] developed an HPLC method, with column switching, for the determination of omeprazole in plasma. The plasma samples were injected onto a Bondapak Phenyl/Corasil (37-50 ym) precolumn and polar plasma components were washed with 0.06 M borate buffer. After valve switching, the concentrated drug were eluted in the back-flush mode and separated on a /i-Bondapack Ci8 column with acetonitrile-phosphate buffer as the mobile phase. The method showed excellent precision, accuracy, and speed with detection limit of 0.01 /ig/ml. Total analysis time per sample was less than 20 min and the coefficients of variation for intra- and interassay were less than 5.63%. The method has been applied to plasma samples from rats after oral administration of omeprazole. 

FdPLC has contributed many successes in product development and in quality control for the pharmaceutical industry. The UV detector coupling with HPLC equipment is the most important analytical instrument for preformulation, QC/QA, and in-process control in pharmaceutical analysis. HPLC is a basic and reliable analytical tool for preformulation study because of the high-resolution capacity, accuracy, and reproducibility of the equipment. Its primary function includes search for and detection of impurities in drug substances, as well as stability evaluation of dosage forms in terms of detection and quantitation of degradation products. 

---