Formulation and stability of topical water in oil emulsion containing corn silk extract

Purpose: To formulate the water in oil (W/O) emulsion of corn silk (CS) extract and to evaluate its stability at various storage conditions. Methods: Ethanol CS extract was prepared using maceration (cold) technique. A 4 % CS emulsion was prepared using varying concentrations of liquid paraffin, ABIL EM90 and water. The formulations were kept at 40 oC for 28 days and to screen out the less stable formulations. The remaining formulations were further stressed at 50 oC to choose the most stable formulation. The optimized formulation was evaluated for physical characteristics including phase separation, rheology and mean droplet size. The physical stability of the formulation was evaluated by monitoring these parameters over a period of 12 weeks at 8, 25, 40 and 40 oC, and 75 % RH. Results: The chosen formulation showed good resistance to phase separation on centrifugation under all storage conditions. Rheological behavior followed non-Newtonian pseudoplastic pattern at various storage conditions. Mean droplet size of freshly prepared formulation was 2.98 ± 1.32 µm and did not show significant (p < 0.05) changes at normal storage conditions (8 and 25 oC). Conclusion: The findings indicate that the developed CS extract W/O emulsion is stable and therefore may be suitable for topical use on skin as an antioxidant preparation.

Liquid chromatographic-mass spectrometric method for determination of drug content uniformity of two commonly used dermatology medications in a split-tablet dosage form

Purpose: To develop and validate a simple, efficient and reliable Liquid chromatographic-mass spectrometric (LC-MS/MS) method for the quantitative determination of two dermatological drugs, Lamisil® (terbinafine) and Proscar® (finasteride), in split tablet dosage form. Methods: Thirty tablets each of the 2 studied medications were randomly selected. Tablets were weighed and divided into 3 groups. Ten tablets of each drug were kept intact, another group of 10 tablets were manually split into halves using a tablet cutter and weighed with an analytical balance; a third group were split into quarters and weighed. All intact and split tablets were individually dissolved in a water: methanol mixture (4:1), sonicated, filtered and further diluted with mobile phase. Optimal chromatographic separation and mass spectrometric detection were achieved using an Agilent 1200 HPLC system coupled with an Agilent 6410 triple quadrupole mass spectrometer. Analytes were eluted through an Agilent eclipse plus C8 analytical column (150 mm × 4.6 mm, 5 μm) with a mobile phase composed of solvent A (water) containing 0.1% formic acid and 5mM ammonium formate pH 7.5, and solvent B (acetonitrile mixed with water in a ratio A:B 55:45) at a flow rate of 0.8 mL min-1 with a total run time of 12 min. Mass spectrometric detection was carried out using positive ionization mode with analyte quantitation monitored by multiple reaction monitoring (MRM) mode. Results: The proposed analytical method proved to be specific, robust and adequately sensitive. The results showed a good linear fit over the concentration range of 20 - 100 ng mL-1 for both analytes, with a correlation coefficient (r2) ≥ 0.999 and 0.998 for finasteride and terbinafine, respectively. Following tablet splitting, the drug content of the split tablets fell outside of the proxy USP specification for at least 14 halves (70 %) and 34 quarters (85 %) of FIN, as well as 16 halves (80 %) and 37 quarters (92.5 %) of TBN. Mean weight loss, after splitting, was 0.58 and 2.22 % for FIN half- and quarter tablets, respectively, and 3.96 and 4.09 % for TBN half- and quarter tablets,respectively. Conclusion: The proposed LC-MS/MS method has successfully been used to provide precise drug content uniformity of split tablets of FIN and TBN. Unequal distribution of the drug on the split tablets is indicated by the high standard deviation beyond the accepted value. Hence, it is recommended not to split non-scored tablets especially, for those medications with significant toxicity