Srikant Pimple

The purpose of this study was to formulate a stable parenteral formulation of Palonosetron HCl 0.05 mg/mL which is pharmaceutically equivalent to Reference Drug Product. Preformulation study was performed to evaluate the compatibility of product with materials which come in contact with the product during manufacturing. Compatibility study was carried out with metal, silicon tubes, PVDF filters and stoppers. Thermal cycling and photostabilty study were also performed to ensure the stability of the product. Palonosetron injection was formulated by dissolving the API and excipients in WFI in a S.S vessel under continuous stirring. Stability studies at different conditions were also performed. Compatibility study results indicate that drug product was compatible with the product contact materials. Thermal cycling and photostabilty data indicates that there was no significant degradation in the formulation. As a part of Sterilization cycle development, terminal sterilization was performed at 1210C for 15, 20 and 30 minutes time intervals and finalized cycle was 20 minutes. A stable Palonosetron Injection was developed and evaluated. Compatibility and accelerated stability studies at different conditions were performed and it can be concluded that the product is compatible with product contact materials, thermal and photostable.

A simple, precise, rapid and specific reversed phase high performance liquid chromatographic method for determination of S (-) Metoprolol Succinate was developed and validated. The chromatographic separation was achieved on Inertsil ODS column (125×4.6mm, 5µ), using a mixture of 20mM potassium dihydrogen phosphate (pH adjusted to 3.5 with ortho-phosphoric acid) and acetonitrile as mobile phase in the ratio of 80:20 at flow rate of 1.5 mL/min. The detection was performed at 220 nm. The calibration curve was linear in the range of 30 - 90 µg/mL (r2 = 0.99999). Major impurities and degradation products were well separated from S(-) Metoprolol Succinate. Thus this assay method can be considered as stability-indicating.