SYNTHESIS AND CHARACTERIZATION OF 6 – HYDROXY – 3, 4 -DIHYDROQUINOLINONE CILOSTAZOL IMPURITY-A AS PER INDIAN PHARMACOPOEIA

Impurity profile study is critical for getting market approval of finished dosage forms from regulatory authorities. There are many manufacturing firms (small and medium scale) in India that they cannot afford the high priced USP reference standards for analysis. So, the availability of cheaper affordable IP reference standards will help them adhere to quality guidelines for active pharmaceutical ingredients (APIs) and drug products and assure safe manufacturing system and marketing of pharmaceutical products. This research work is mainly envisaged towards increasing the list of Indian Pharmacopeia (IP) approved impurity reference standards. This paper describes our efforts towards the synthesis and process optimization of the synthesis of cilostazol impurity A. The objective of the present work was to develop a simple route of synthesis that gave a high purity product with good process efficiency. The synthesized cilostazol impurity A was characterized using sophisticated analytical techniques like Fourier-Transform Infrared spectroscopy (FTIR), Nuclear Magnetic Resonance (NMR) and Liquid Chromatography Mass spectrometry (LC-MS). The results indicated that cilostazol impurity A was obtained in a high purity form (>99.0%) using the developed synthetic process that could be scaled up and subsequently used for manufacturing of cilostazol impurity A reference standard.