Posted by admin on Dec 31, 2022 in |
A simple, specific, accurate, reliable, and precise reverse-phase high-performance liquid chromatographic method was developed by quality by design approach and validated for the estimation of Capecitabine in bulk and tablet dosage forms. A surface methodology was used to optimize the data with a three-level Box Behnken Design (BBD) was used. Mobile phase composition, flow rate, and column oven temperature were chosen as the three variables. The linearity was over the concentration range of 1-15 μg/ml with a correlation coefficient of 0.999. The LOD and LOQ were found to be 0.103 ug/mL and 0.313 ug/mL, respectively. Chromatographic separation was carried out by using a mobile phase of methanol: water (70:30 V/V) on Kromasil C18 column (250 mm X 4.6mm ID, 5 μm) in an isocratic mode at a flow rate of 0.9 ml/min with UV detection at 239 nm. The developed RP-HPLC method yielded a suitable retention time for Capecitabine of 4.70 min, which was optimized using the Design-Expert version 7.0.0. The percentage recovery was found to be 99.81%. The...
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Posted by admin on Dec 31, 2021 in |
Quality by Design (QbD) is an essential part of modern pharmaceutical development. QbD is a requisite for the design and development process for the pharmaceutical industry. QbD assists and encourages both the industries and FDA to inculcate a proactive, scientific and risk-based approach in the process and product development. It is based on a concept of building quality right from the start of the process rather than the final quality test of the finished product. An effective QbD approach provides insights and essential upstream throughout the development process which ultimately ends up offering a successful plan that reduces batch failures and recalls. It is also known as a structured lifecycle of product development and management. This review aims to present an overview of QbD implementation, its tools, elements, and methodologies, the involved ICH Guidelines, and the application in the current pharmaceutical sector. Under QbD, it is important to define the desired product performance profile i.e., Quality Target Product Profile (QTPP) and analyze, Critical Quality Attributes (CQA), Critical Process Parameter...
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Posted by admin on Dec 31, 2021 in |
An accurate, simple, precise, rapid stability-indicating assay method was developed and subsequently validated for the estimation of Telmisartan in API and Tablets. The best separation of the drug was achieved on Kromasil C18 (4.6 × 150 mm, 5 µm) with the mobile phase consisted of mixture of 0.01 M Phosphate buffer (pH: 3) and Acetonitrile in ratio of (40:60%) at flow rate of 2 ml/min, with detection at 226 nm using PDA detector. The retention time was found to be 2.728 min. The method was found to be linear in the range of 10-60 µg/ml with a correlation coefficient (r2) of 0.999. The LOD and LOQ of the method were calculated to be 0.256 and 0.776 µg/ml, respectively. The Precision was estimated by employing repeatability; intra-day and inter-day studies and the results were calculated as %RSD values and were found to be within the acceptable limits. Recovery of the drug was found to be in the range of 97-102%, which establishes the accuracy of the method. Forced degradation studies...
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Posted by admin on Dec 31, 2021 in |
Leishmaniasis is a neglected tropical infectious disease affecting poor people, especially in the developing countries of the world. It is a systemic disease caused by a protozoan parasite leishmania donovani and is fatal if left untreated. The aim of the present study is to develop and evaluate the in-vitro antileishmanial activity of the combination of amphotericin B and mitefosinenano vesicles for targeted delivery to macrophages in the treatment of visceral leishmaniasis to increase the efficacy, decrease emergency of resistance and increase overall patient compliance. Drug-loaded nanovesicles were prepared by ethanol injection method. Physicochemical characterization and cytotoxicity, and antileishmanial activity evaluations were assessed. Nanovesicles of optimal AmB-MTF formulation was prepared from phosphatidylcholine-cholesterol-stearic acid (20:4:1 w/w) lipids, ethanol-water (1:4 v/v) dispersion medium, and AmB-MTF (1:1 w/w) drugs at drug loading of 1:8 and stirring rate of 1000 rpm. AmB-MTF 1:1 nanovesicles exhibited a mean particle size of 145.6 nm, polydispersity index (PDI) 0.19, zeta potential -27.3 mV and drug entrapment efficiency 87%. The AmB-MTF combination nanovesicles demonstrated low CC50 against J774...
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Posted by admin on Dec 31, 2021 in |
Topical formulations may contribute to the reduction of oxidative stress in the skin. Banana peel is a fruit waste with antioxidant activity that is not yet included in a topical formulation. The aim of this study was to evaluate the antioxidant and anti-aging activity of a cream formulation containing a lyophilized extract of banana peel. The banana peel was extracted with ethanol, and a cream formulation containing 1% of the resulting extract was prepared. The total phenolic content (TPC), total flavonoid content (TFC), antioxidant and anti-aging activity of both extract and formulation were investigated. DPPH (2, 2-Diphenyl-1-picrylhydrazyl) free radical scavenging, ABTS (2, 2′-Azinobis (3-ethylbenzotrazole-6-sulfonate) cation radical scavenging, FRAP (Iron ion reduction) and CUPRAC (copper ion reduction) methods were used for antioxidant effect. For the anti-aging effect, elastase enzyme inhibitory activity was studied. The banana peel extract had a high antioxidant and anti-aging effect compared to the standards. Although the extract was added 1% in the cream, the cream showed antioxidant and anti-aging effects of about 80% of the extract....
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