HPLC analysis of crude drug picoplatin and its stability

Objective: To develop a new HPLC method for an easy and rapid determination of picoplatin,and investigate its purity and its stability in acid,alkaline,oxidative and reductive conditions through this method.Methods: The Waters XTerra PR C18( 250 mm × 4. 6 mm,5 μm) column was used with a water solution of 15%acetonitrile as the mobile phase,and the photo-diode array detector was used to detect and analyze the purity between 200 nm and 400 nm. The stability of picoplatin in acid,alkaline,oxidative and reductive conditions was investigated by the addition of HCl,Na OH,H2O2 and Na HSO3 into the solution and HPLC was used for content determination. Results: This method could rapidly and sensitively determine picoplatin content. The calibration curve was linear within the concentration range of 0. 02-0. 2 mg·m L-1( R2= 0. 999 9). The limit of detection was 0. 094 ng and limit of quantification was 0. 022 ng. The method can separate picoplatin from cisplatin,potassium trichloroammine platinate and cis-amminedichloro( 3-methylpyridine) platinum effectively. The purity analysis indicated that picoplatin( API) had high purity in the three batches of test preparations. And the stability test revealed that picoplatin was unstable in alkaline and oxidative conditions. Conclusion: The developed method is suitable for the content determination of picoplatin and its test and monitoring during the preparation process. And picoplatin should be avoided contacting with alkaline and oxidizing substances during storing and studying of preparation.