A sensitive stability-indicating reversed-phase high performance liquid chromatographic method was developed for the simultaneous determination of mometasone furoate (MON), oxymetazoline (OXY), phenyl ethanol (PEL) and benzalkonium chloride analogs (BKC1and BKC2) in nasal spray solution. The chromatographic separation was achieved on Cosmosil CN 150 mm x 4.6mm, 5 um column Using a mobile phase consisting of 50 mM KH2PO4 and Acetonitrile in the ratio of 60:40 (v/v), at a flow rate of 2.0 ml/min. The column compartment temperature was set at 40°C. The typical HPLC chromatograms were extracted at 215 nm using a photodiode-array detector (PDA). The inter-day and intra-day precision values are found within 2% of relative standard deviation. The described method gives LOQ values of 21 ng/mL for MON, 23 ng/mL for OXY, 25 ng/mL for PEL, 10 ng/mL for BKC1 and 9 ng/mL for BKC2. The method shows accuracy of 99.6% for MON, 99.8% for OXY, 99.8% for PEL, 99.0% for BKC1 and 99.5% for BKC2. The described method shows excellent linearity over a range of LOQ to 150% of test concentration. The correlation coefficient for MON, OXY, PEL, BKC1 and BKC2 was 0.9998, 0.9999, 0.9998, 0.9999 and 0.9996 respectively.
A reversed-phase gradient liquid chromatographic method has been developed for the quantitative determination of Voriconazole, along with its degradation and diastereomeric impurities in tablet dosage form. Chromatographic separation has been achieved on an Inertsil ODS 3V, 150 × 4.6 mm, 5 μm column. The mobile phase consisting of solvent A 0.05 molar (M) potassium dihydrogen phosphate (pH 2.5 buffer) and solvent B (mixture of acetonitrile and methanol in the ratio 90:10 (v/v)), was delivered at a flow rate of 1.2 mL min−1 with the detection wavelength at 256 nm. Resolution of Voriconazole and all five potential impurities was achieved at greater than 2.0 for all pairs of compounds. The drug was subjected to stress conditions such as oxidative, acid and base hydrolysis, and thermal and photolytic degradation. Voriconazole was found to degrade significantly under base hydrolysis stress conditions compared to acid hydrolysis stress conditions. The degradation products were well-resolved from the main peak and its impurities, thus proving the stability-indicating power of the method. The stressed samples were assayed against a reference standard and the mass balance was found to be close to 99.0%. The developed method was validated as per ICH guidelines with respect to specificity, linearity, limit of detection, limit of quantification, accuracy, precision, and robustness.
In this research, hydrogel biocomposites were prepared from whey protein isolate (WPI), reduced graphene oxide (rGO), and synthetic polymers in varied ratios. Their physicochemical properties were evaluated by FTIR, SEM, TGA, AFM, and TEM. FTIR spectra revealed significant peaks at 1167 cm −1 for C-O-C peak and at 1449 cm −1 for O-H bending for WPI and rGO, respectively. The hydrogels were loaded with proguanil hydrochloride and chloroquine diphosphate and in vitro release kinetics of individual drugs from the biocomposites were studied. The SEM images of the biocomposites after drug release confirmed that they are biodegradable. The drug release was controlled, pH-dependent which further confirmed that the hydrogels are pH-sensitive. The release of proguanil from the hydrogels was slow when compared to chloroquine, suggesting that the solubility of the drug influenced their rate of release. The drug release from the biocomposites fitted the Korsmeyer-Peppas model with n values for chloroquine between 0.46 and 0.49 at pH of 1.2 and between 0.72 and 1.41 at pH of 7.4. The n values for proguanil were between 0.66 and 0.83 at pH 1.2 and 0.85-0.92 at pH 7.4. The results obtained suggested that the biocomposites are potential systems that can be tailored for controlled delivery of bioactive agents.
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