Aims: To develop and validate a new, simple, rapid, precise, and accurate An Eco-friendly RP-HPLC and UV-Method Development and Validation for an estimation of Favipiravir in Bulk and pharmaceutical dosage form followed by Forced Degradation Studies. Study Design: This was employed for UV-visible (200-400 nm and 400-800 nm respectively) and RP-HPLC method development using C 18 inertsil column and optimization of variables for Favipiravir estimation in bulk and formulations. Place and Duration of the Study: The present work was carried out at Ali-allana College of Pharmacy, Akkalkuwa between the duration of November-2020 to February-2021. Methodology: UV-Spectroscopic method was developed for the estimation of Favipiravir in the bulk and pharmaceutical dosage form. The solvent selected for the Favipiravir UV analysis was water, the solution in a range of 2-10µg/ml was scanned in the UV region from 200-400 nm and the λmax value was determined. The RP-HPLC method was developed on inertsil ODS-3V C18 150 mm x 4.6mm x 5μ column using buffer pH 3.5: acetonitrile [90:10] as mobile phase at flow rate 1.0 ml/min and PDA detection at 358 nm. Results: The maximum absorbance was observed at 358 nm. The wavelength 358 nm was selected for further analysis of Favipiravir. The calibration curve was determined using drug concentrations ranging from 2-10 µg/ml. The % recovery for accuracy was 100.50-100.76%. The method was to be precise with a % RSD value 0.51-1.37 and 0.77-1.78 for intraday and Interday respectively. The limit of detection (LOD) and limit of quantification (LOQ) was found to be 0.0723 &0.219 µg/ml respectively by UV method. The RP-HPLC method was shown to be linear in the 50-250 μg/ml concentration range. The limit of detection (LOD) and limit of quantification (LOQ) was found to be 2.186 & 6.626 μg/ml respectively. The method was to be precise with a % RSD value 0.25-1.53 and 0.86-1.68 for intraday and inter-day respectively. Conclusion: Here we conclude that the developed UV and RP-HPLC methods are precise, accurate, sensitive, and reproducible for the quantitative estimation of Favipiravir bulk and its formulation. The developed method can be used by the pharmaceutical industries for the routine analysis of Favipiravir, in particular by UV and RP-HPLC. The main features of the proposed method are economic and eco-friendly with less retention time around 5.0 min.
Recent development in fast disintegrating technology mainly works to improve the quality of these delicate dosage forms without affecting their integrity. Current investigations deal with the formulation of fast dissolving tablet of Ondansetron HCl with the effect of different co-processed excipients by using ball mill that disintegrates in oral cavity on contact with saliva & thereby improve therapeutic efficacy because the mannitol was stick to dies and punch therefore ball mill is used to prepare co ground mixtures of crospovidone and mannitol to improve the compatibility and stability of product. The Fast disintegrating tablets of Ondansetron HCl were prepared by direct compression method using different synthetic superdisintegrant such as Crospovidone, and natural superdisintegranst such as Karaya gum and Fenugreek gum in different concentration. The FTIR, DSC analysis revealed that the Betacyclodextrin and superdisintegrants used were compatible with Ondansetron HCl. A complex of Betacyclodextrin and Ondansetron HCl was successfully formed in 1:2 ratios. Disintegration time decrease with increase in the concentration o superdisintegrant. Among all formulation, containing Karaya Gum as superdisintegrants is fulfilling all the parameters satisfactorily. In vitro release studies that almost 98.88% of the drug was released from all the formulation were within 15 minutes. Best Formulation F6 showed faster drug release within 7 minutes in comparison to other formulation. ThE result shows that Coprocessing of excipients is the most suitable approach for formulation of Fast dissolving tablet.
The aim of the work is to design Gastroretentive tablets of Ondansetron HCl for gastric retention by using 3 2 factorial designs. Floating tablets of Ondansetron HCl were prepared by direct compression method using polymers, sodium alginate and excipient. Gastroretentive tablets of Ondansetron HCl were successfully prepared by effervescent technique using different gel forming polymers-HPMC K200M, and sodium alginate. Formulation was optimized by design expert software. Floating tablets were evaluated for floating time, floating lag time, drug content, raft measurement and in vitro dissolution profile. The lag time is between 17-22 sec and floating time of the formulations for 12 hrs. The best fit model is Korsemeyer Peppas Model. From the study it is proof that the sustain release by floating tablets of Ondansetron HCl can be develop. Optimized batch selected was A3, The prepared gastroretentive test formulation was found to exhibit satisfactory physico-chemical characteristics at the end of 3 months, during the stability studies. The optimized formulation A3 was found to be stable at 40 0C / 75% RH.
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