A simple, economic, rapid, reliable, and stability-indicating high-performance liquid chromatography (HPLC) method has been developed and validated for the simultaneous determination of paracetamol (PCM) and caffeine (CF) in solid dosage form. The chromatographic separations were achieved with a Waters Symmetry W C18 column (5 μm, 4.6 × 150 mm), using a mixture of methanol and water (40:60, v/v) as a mobile phase, under isocratic elution mode with a flow rate of 0.8 mL/min, and ultraviolet (UV) detection was set at 264 nm. The oven temperature for the column was set and maintained at 35 °C. The method was validated according to International Conference on Harmonization (ICH) guidelines, and it demonstrated excellent linearity, with a correlation coefficient of 1 and 0.9999 for PCM and CF, respectively, over the concentration ranges of 15-300 μg/mL (PCM) and 2.5-50 μg/mL (CF). The retention time (t R ) was found to be 2.6 ± 0.001 and 3.5 ± 0.002 min for PCM and CF, respectively. Extensive stress degradation studies were conducted by subjecting the analytes to various stress conditions of acidic and alkaline hydrolysis as well as oxidative, photolytic, and heat degradations. The method was found to efficiently separate the analytes' peaks from that of the degradation products, without any variation in their retention times. The relative standard deviation (RSD) values of all recoveries for PCM and CF were less than 1.3%. The method was found to be suitable for routine analysis of PCM and CF in pharmaceutical dosage form.
Objective
Burn injuries are among the most common accidental health problems worldwide, frequently leading to health and socio-economic challenges. Despite this, no standard protocol for managing burn injuries can overcome the adverse effects of currently used drugs. The present study sets out to develop and evaluate the efficacy of new herbal ointments in providing synergistic anti-inflammatory, antimicrobial, antioxidant, and cell-proliferating activities. It also investigates the high-performance liquid chromatography (HPLC) characterisation of these new herbal ointments.
Method
Three different concentrations of the new herbal ointment, which incorporates extracts of
Matricaria aurea
flower heads, arial parts of
Calendula tripterocarpa
,
Rosmarinus officinalis
leaves,
Alkanna tinctoria
roots, and myrrh were developed and evaluated. Ointments designed to promote burn-wound healing were prepared and compared with β-sitosterol ointment and silver sulfadiazine cream, as a commercial standards.
Results
According to statistical and histopathological analyses and visual inspections, the new herbal formulas showed faster wound healing, more tolerability, and less toxicity than the commercial standards.
Conclusion
The new herbal ointments, developed in our study, have shown promising results. The formula offers mechanical protection without any release of non-biodegradable particles. It maintains the optimum moisture and pH of the skin, while minimising scar-tissue formation. These advantages, in addition to availability, low costs, and easy handling, may support the use of this new herbal formula as an effective and safe alternative treatment, designed to promote the healing of burn injuries.
Solid dispersion (SD) formulation has attracted much attention due to its potential in enhancing dissolution performances of poorly soluble active pharmaceutical ingredients (API). Recently, a review on dissolution performances of SDs classifies the improvement into 3 categories, where 82 % of the studies showed improved bioavailability, 8 % showed reduced bioavailability and 10 % revealed similar bioavailability as compared to pure APIs. This indicates the inconsistent degrees of dissolution improvement of poorly soluble APIs in SD. Although a few factors related to the choice of carriers have been suggested to contribute to the dissolution improvement, however, the underlying factor determining the discrepancy in the degree of dissolution improvement remains in vague. It is hypothesized that the API contributes to the degree of dissolution improvement of SD. Hence, the factor of amorphous solubility advantage of API which leads to the different degrees of dissolution enhancement of SD is investigated in this research. Polyvinylpyrrolidone vinyl acetate (PVPVA)-based SD is prepared with three poorly soluble APIs. Physicochemical properties of SD were characterized using infrared spectroscopy, differential scanning calorimetry (DSC) and X-ray powder diffraction. The dissolution efficiency of each SD was calculated and compared to physical mixture and pure API. Theoretical amorphous solubility advantage for each API was calculated using the thermal properties obtained from DSC. The calculated values were found to be correlating well with the dissolution enhancement of the respective SDs. Hence, this theoretical approach can be utilized as an initial screening tool of API candidates in SD formulation during early pharmaceutical development.
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