pharmaceutical analysis.

New ion – associate complexes of the two gliptin drugs, vildagliptin and saxagliptin were precipitated with tetraiodometrcurate and ammonium reineckate and the excess unreacted metal complex was determined. New methods were given for the determination of these drugs in pure solutions, pharmaceutical formulations and urine samples using atomic absorption and atomic emission spectrometry. The drugs can be determined by the afford methods  in the ranges 0.68 – 74.69 and 0.70 – 77.42 μg / ml for vildagliptin and saxagliptin, respectively.

To assure the quality of drugs, impurities must be monitored carefully. It is important to understand what constitutes an impurity and to identify potential sources of such impurities. Selective analytical methods need to be developed to monitor them. It is generally desirable to profile impurities to provide a yardstick for comparative purposes. New impurities may be observed as changes are made in the synthesis, formulation, or production procedures, albeit for improving them. At times it is necessary to isolate and characterize an impurity when hyphenated methods do not yield the structure or when confirmation is necessary with an authentic material. Availability of an authentic material can also allow toxicological studies and provide a standard for routine monitoring of the drug product.