Entity

Time filter

Source Type

Alexandria, Egypt

Eldeen E.M.S.,Pharco Corporation | Etman M.A.,Alexandria University | Aboul-Enein H.Y.,Pharmaceutical and Drug Industries Research Division
Gazi University Journal of Science | Year: 2012

A simple, rapid and precise gas chromatographic method has been developed for simultaneous determination of seven volatile compounds namely alpha pinene, camphene, beta pinene, cineole, fenchone, borneol and anethol in urinary tract antiseptic soft gelatine capsule. The seven compounds were analysed by Gas chromatography-flame ionization detector (GC-FID) on a (5% diphenyl and 95% dimethylpolysiloxane) (30m x0.25mm x 0.25μm) column and Helium as a carrier gas. The injector and detector port temperatures were maintained at 200°C and 250°C respectively. Results of assay and recovery studies were statistically evaluated for its accuracy and precision. The correlation coefficient (r) values ranged from 0.997 to 0.9998. The detection limits ranged from 0.0015 to 0.014 mg ml -1. No interference from any components of pharmaceutical dosage forms was observed. According to the validation results, the proposed method was found to be specific, accurate and precise and could be applied to the simultaneous quantitative analysis of these seven volatile compounds in such pharmaceutical formulation. Source


Seifeldeen E.M.,Pharco Corporation | Etman M.A.,Alexandria University | Aboul-Enein H.Y.,National Research Center of Egypt
Journal of Liquid Chromatography and Related Technologies | Year: 2016

A rapid, accurate, and precise HPLC method has been developed for simultaneous determination of four contraceptive hormonal compounds namely ethinylestradiol (EE), drospirenone (DR), gestodene (GS), and levonorgestrel (LV) in oral contraceptive tablet dosage form. The chromatographic separation was achieved on a C18 (150 × 4.6 mm, 5) column; the mobile phase consists of acetonitrile: water (50:50, v/v) pumped at a flow rate of 1.0 mL/min; and UV detection was set at 200 nm. The limit of detection was 0.0086 μg/mL for (EE), 0.0397 μg/mL for (GS), 2.80 μg/mL for (DR), and 0.229 μg/mL for (LV), whereas the limit of quantitation (LOQ) was 0.028 μg/mL for (EE), 0.132 μg/mL for (GS), 9.500 μg/mL for (DR), and 0763 μg/mL for (LV), respectively. The correlation coefficient (r) values of the four compounds ranged from 0.99995 to 0.99999. The method was validated as per ICH guidelines and USP 34 for estimation of (EE), (DR), (GS), and (LV) in commercially available tablet dosage form. The validation results were found satisfactory. The proposed method can be useful in quality control of bulk manufacturing and pharmaceutical dosage forms. © 2016 Taylor & Francis. Source


Elgindy N.,Alexandria University | Elkhodairy K.,Alexandria University | Molokhia A.,Pharco Corporation | Osman Elzoghby A.,Alexandria University
Drug Development and Industrial Pharmacy | Year: 2011

Context: Flutamide (FLT) has poor aqueous solubility and low oral bioavailability. Objective: Lyophilization monophase solution was used for preparing lyophilized dispersions of FLT with polyols and amino acids to increase its poor dissolution. Methods: Physical properties and dissolution behavior of their physical mixtures and lyophilized dispersions were investigated. Results and discussion: The carriers increased the aqueous solubility of FLT but to a limited extent with arginine and glycine showing a linear AL-phase solubility diagrams. Gas chromatography indicated that residual tertiary butyl alcohol was in range of 0.007-0.023% (w/w) in the dispersions. In all dispersions, the crystal structure of FLT was confirmed using differential scanning calorimetry, X-ray diffractometry, and scanning electron microscopy. However, the percent drug crystallinity was found to decrease with increasing the carrier content. Infrared spectroscopy revealed no interaction between drug and carriers. The particle size of FLT dispersions ranged between 0.61 and 1.81 μm, with a high surface area (293.93-465.37 m2/g) and porosity (447.69-754.33 e-3 mL/g). In addition, the poor flow properties of FLT were improved but to a limited extent. FLT dissolution from the dispersions was enhanced with 46.35% and 36.43% of FLT dissolved after 30 minutes from 1:5 FLT-mannitol and FLT-trehalose dispersions, respectively, compared with only 13.45% of pure FLT. On the other hand, after 30 minutes 38.57% and 46.78% of FLT was dissolved from 1:3 FLT-arginine and FLT-glycine dispersions, respectively. Conclusion: These data suggest that polyols and amino acids might be useful adjuncts in preparation of immediate-release formulations of FLT. © 2011 Informa UK, Ltd. Source


Elgindy N.,Alexandria University | Elkhodairy K.,Alexandria University | Molokhia A.,Pharco Corporation | Elzoghby A.,Alexandria University
Drug Development and Industrial Pharmacy | Year: 2011

Flutamide (FLT) is a poorly soluble anticancer drug. Therefore, lyophilized dispersions (LDs) of FLT with polyvinylpyrrolidone (PVP) K30, polyethylene glycol (PEG) 6000, and pluronic F127 were prepared via lyophilization monophase solution technique with the aim of increasing its dissolution rate. FLT showed an AL-type phase solubility diagrams with PVP and PEG, whereas AN-type diagram was obtained with pluronic. The amount of residual tertiary butyl alcohol, determined by gas chromatography, was 0.015-0.021% w/w. Differential scanning calorimetry and X-ray diffractometry revealed that FLT-polymer 1:1 LDs were partially amorphous, whereas the 1:3 and 1:5 LDs were completely amorphous. After 6 months storage, polymers under study inhibited FLT recrystallization maintaining its amorphous form. The particle size of FLT-polymer LDs was between 0.81 and 2.13 μm, with a high surface area (268.43-510.82 m2/g) and porosity (354.01-676.23 e-3 mL/g). Also, the poor flow properties of FLT could be improved but to a limited extent. FLT dissolution was significantly enhanced with the fastest dissolution that was achieved using pluronic. After 30min, about 66.52%, 78.23%, and 81.64% of FLT was dissolved from 1:5 FLT-PVP, PEG, and pluronic LDs, respectively, compared with only 13.45% of FLT. These data suggest that these polymers might be useful adjuncts in preparation and stabilization of amorphous immediate-release FLT LDs. © 2011 Informa Healthcare USA, Inc. Source


Elgindy N.,Alexandria University | Elkhodairy K.,Alexandria University | Molokhia A.,Pharco Corporation | Elzoghby A.,Alexandria University
European Journal of Pharmaceutics and Biopharmaceutics | Year: 2010

Flutamide (FLT), an anticancer drug for prostatic carcinoma, has poor aqueous solubility and low oral bioavailability. This study describes the ability of β-cyclodextrin (βCD) and hydroxypropyl-β-cyclodextrin (HPβCD) to form complexes with flutamide with enhanced solubility and dissolution rate in vitro. FLT-CD lyophilized dispersions (LDs) were prepared via lyophilization monophase solution technique using tertiary butyl alcohol (TBA) as a cosolvent. FLT showed an AL-type phase solubility diagram consistent with a linear increase in drug solubility as a function of CD concentration. Gas chromatography indicated that the LDs contain 0.02-0.03% w/w residual TBA. Based on the data from differential scanning calorimetry (DSC) and X-ray diffractometry (XRD), FLT was fully amorphous in 1:5 FLT-HPβCD LD as indicated by complete disappearance of FLT endothermic and diffraction peaks. The Fourier transform infrared (FTIR) spectra indicated that a FLT-CD interaction took place in the lyophilized complex. The particle sizes of 1:1 FLT-βCD and FLT-HPβCD LDs were 0.92 and 0.82 μm, with a high surface area (484.55 and 705.68 m2/g) and porosity (769.46 and 1020.99 e-3ml/g), respectively. The dissolution rate of FLT from its CD complexes was enhanced significantly. After 30 min in 0.1 N HCl, about 73% and 86% of FLT were dissolved from 1:5 FLT-βCD and FLT-HPβCD LDs, respectively, compared to only 13.45% of pure drug. No endothermic peak corresponding to FLT melting was detected in 1:5 FLT-HPβCD LD after storage at 20 °C and 45% relative humidity for 90 days thus indicating the stability of this binary system. These data suggest that cyclodextrins might be useful adjuncts in preparation of immediate-release formulations of FLT. © 2009 Elsevier B.V. All rights reserved. Source

Discover hidden collaborations