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Title: Preformulation studies of fluvastatin sodium with polyvinyl pyrollidone K-30 and polyethylene glycol 6000
Authors: Sharma N
Singh S
Kaur G
Arora S.
Keywords: Pre-formulation
Fluvastatin sodium (FSS)
Polyvinyl pyrollidone K-30 on drying
Issue Date: 2019
Publisher: Plant Archives
Abstract: The purpose of this pre-formulation work was to accomplish physicochemical characterization and compatibility analysis of fluvastatin sodium (FSS) with polyvinyl pyrollidone K-30 (PVP K30) and polyethylene glycol 6000 (PEG 6000). Melting point, log P and hygroscopicity estimation of FSS was executed by capillary; shake flask and european pharmacopeia method, respectively. Residue on ignition (% ROI) was determined according to ICH Q4B R1. Increase in weight of FSS was <0.2% which signified its non-hygroscopic nature. Melting point, log P, % loss on drying and % ROI of FSS was found 195 � 5 �C, 3.9, 0.34 % (? 0.5%) and 0.03 % (? 0.1%), respectively. Abundant spiky crystalline peaks in x-ray diffraction pattern of FSS confirmed extremely crystalline nature of drug. FSS was found freely soluble in acetone, soluble in water, ethanol, methanol and phosphate buffer (pH 7.4) while very slightly soluble in chloroform and dichloromethane. Differential scanning calorimetry demonstrated compatibility of FSS with PEG 6000 and PVP K30.
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