Box-Behnken Design (BBD) Application for Optimization of Chromatographic Conditions in RP-HPLC Method Development for the Estimation of Thymoquinone in Nigella sativa Seed Powder

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Abstract

Thymoquinone (THY) is a bioactive compound present in the seed powder of Nigella sativa (NS). This research aims to precisely and accurately estimate THY using high-performance liquid chromatography (HPLC) with a Quality by Design (QbD) application. Box-Behnken design (BBD) was employed to optimize the chromatographic conditions for HPLC method development, taking mobile phase flow rate, pH of the buffer, and λmax as independent variables and retention time and tailing factor as the measured responses. The mobile phase composition was methanol: acetonitrile: buffer (2.2 mM ammonium formate) at the ratio of 35:50:15 v/v/v on a Symmetry® C18 (5 μm, 3.9 × 150 mm) column. In isocratic mode, it had a flow rate 0.9 mL min−1 and eluted analyte was detected at 249 nm. Validation parameters followed the International Council for Harmonization (ICH) guidelines for the new HPLC method. The method was linear over the range 6.25–100 µg mL−1 with a coefficient of determination (r2) of 0.9957. The limit of detection (LOD) and limit of quantification (LOQ) were 2.05 and 6.25 µg mL−1, respectively. The %RSD of system suitability for retention time was 1.42% and for the tailing factor it was 0.695%. In addition, the developed method was precise, accurate, and robust according to ICH criteria. The developed HPLC method is simple, accurate, quick, and robust, and it could be used for the routine analysis of THY in different kinds of formulations.

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Techniques for extraction and isolation of natural products: a comprehensive review

Qing-Wen Zhang, Li-Gen Lin, Wen-Cai Ye (2018)

Natural medicines were the only option for the prevention and treatment of human diseases for thousands of years. Natural products are important sources for drug development. The amounts of bioactive natural products in natural medicines are always fairly low. Today, it is very crucial to develop effective and selective methods for the extraction and isolation of those bioactive natural products. This paper intends to provide a comprehensive view of a variety of methods used in the extraction and isolation of natural products. This paper also presents the advantage, disadvantage and practical examples of conventional and modern techniques involved in natural products research.

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Pharmaceutical quality by design: product and process development, understanding, and control.

Lawrence Yu (2008)

The purpose of this paper is to discuss the pharmaceutical Quality by Design (QbD) and describe how it can be used to ensure pharmaceutical quality. The QbD was described and some of its elements identified. Process parameters and quality attributes were identified for each unit operation during manufacture of solid oral dosage forms. The use of QbD was contrasted with the evaluation of product quality by testing alone. The QbD is a systemic approach to pharmaceutical development. It means designing and developing formulations and manufacturing processes to ensure predefined product quality. Some of the QbD elements include: Defining target product quality profile; Designing product and manufacturing processes; Identifying critical quality attributes, process parameters, and sources of variability; Controlling manufacturing processes to produce consistent quality over time. Using QbD, pharmaceutical quality is assured by understanding and controlling formulation and manufacturing variables. Product testing confirms the product quality. Implementation of QbD will enable transformation of the chemistry, manufacturing, and controls (CMC) review of abbreviated new drug applications (ANDAs) into a science-based pharmaceutical quality assessment.

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Black cumin (Nigella sativa) and its constituent (thymoquinone): a review on antimicrobial effects

Fatemeh Forouzanfar, Bibi Sedigheh Fazly Bazzaz, Hossein Hosseinzadeh (2014)

Nigella sativa seeds have wide therapeutic effects and have been reported to have significant effects against many ailments such as skin diseases, jaundice, gastrointestinal problems, anorexia, conjunctivitis, dyspepsia, rheumatism, diabetes, hypertension, intrinsic hemorrhage, paralysis, amenorrhea, anorexia, asthma, cough, bronchitis, headache, fever, influenza and eczema. Thymoquinone (TQ) is one of the most active constituent and has different beneficial properties. Focus on antimicrobial effects, different extracts of N. sativa as well as TQ, have a broad antimicrobial spectrum including Gram-negative, Gram-positive bacteria, viruses, parasites, schistosoma and fungi. The effectiveness of N. sativa seeds and TQ is variable and depends on species of target microorganisms. The present review paper tries to describe all antimicrobial activities that have been carried out by various researchers.