Objectives The analytical method development and validation for the determination of Favipiravir (FVPR) in pure and tablet dosage forms by LC/MS-MS Technique. Materials and Methods A simple LC-MS/MS method was developed for the determination of a new antiviral drug, FVPR in pharmaceutical formulations the separation process was conducted using a Waters X-Bridge Phenyl Hexyl column (150x4.6 mm, 3.5 μm). The elution method employed was isocratic, involving a buffer solution consisting of 1 mL of Formic acid in 1 Litter of water. The mobile phase consisted of a mixture of two components: the aforementioned buffer and Acetonitrile in a 60:40 v/v ratio. The elution was maintained at a flow rate of 1 mL/min, as well as the entire process was carried out at room temperature. The proposed method was validated according to the International Conference on Harmonization (ICH) guidelines. The established method found better outcomes. Results The linearity graph was found in the range of 2-40 ngmL-1, and the correlation coefficient value (R2) obtained was found to be 0.9997. The limit of detection and limit of quantification were 4.044 ngmL-1 and 12.253 ngmL-1, respectively. Tremendous recovery outcomes were observed and found to be 99.49%, 100.09.0% and 100.21% for the FVPR at 150% upper, 100% middle and 50% lower concentrations, respectively. For studying Favipiravir, an electrospray ionization source was employed, with ion pairs of mass analysis at m/z 560.28→158.63 for Favipiravir and m/z 607.33→193.48 for the Internal Standard (IS), which was Zanamivir in this case. Conclusion All obtained outcomes were complying with the ICH guidelines. The developed method was simple, unique, accurate, robust, precise, and reproducible for the determination of FVPR in tablet formulation. The method is novel and could be adopted in the formulation industry.
1 January 2019 in Asian Journal of Pharmacy and Pharmacology
The aim of the present study was to formulate, develop and evaluate ophthalmic solution containing Tafluprost. The selected prostaglandin analogue belongs to BCS - II. So to increase the solubility of the Tafluprost in WFI Beta Cyclodextrin was used by performing various trials variables of the experiments procedure Stirring time and speed were optimized to enhance the solubility. From the experimental procedure with different trails 20mg/mL of Cyclodextrins was fixed for the optimized formula. The product were characterized for appearance, physical state, colour and odour of the drug characteristics. The prepared formulations were evaluated for pH, osmolality and assay and found to be in acceptable ranges. Stability study was carried out for optimized formulation at 40°C±2°C /NMT 25%RH and 30°C ±2°C/ 65%±5% RH for 3 months, were evaluated for pH ,osmolality ,assay found to be within acceptable limits. Finally it can be concluded that the in house product Tafluprost ophthalmic solution was met with in the specification.
Ondansetron HCl is a widely used drug in the treatment of chemotherapy induced nausea and vomiting; post operative nausea and vomiting. It is a weakly basic drug with pH dependent drug release. The drug is practically highly ionised in acidic pH (1.2), precipitated in higher pH of small intestine. Hence, in the present study, it was tried to achieve pH-independent drug release. We adopted a very simple technique formulation containing two different polymers such as an anionic (sodium alginate) and nonionic (HPMCK100). It was found that the formulation F8 (intra and extra granulation technique) showed good correlation drug release in both SGF pH 1.2 and pH 6.8 phosphate buffer.