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Ashwagandha (Withania somnifera) is a very popular medicinal herb originated mainly in India and found in the Middle East and parts of Africa. Ashwagandha has gained recognition as the most revered plant in Ayurvedic medicine. Studies indicated that it is used as anxiolytic, anti-inflammatory, antioxidant, adaptogen, memory enhancer, and possess an effect on neurodegenerative diseases. Additionally, it was revealed that the plant exerts antibacterial, antiviral, antitumor, aphrodisiac, and cardiovascular protection activities. Due to the biological and nutritional importance of nutraceuticals, particularly ashwagandha, and as part of the ongoing research of the natural products and its bioactive phytochemicals, this review aims to summarize the recent analytical techniques that have been reported for the determination of different chemical constituents of Withania somnifera quantitatively and qualitatively, and to highlight new challenges.

Indacaterol, is an ultra-long-acting β2 agonist, glycopyrronium is a long-acting muscarinic-antagonist and mometasone is a synthetic corticosteroid. They were used recently in combination for the treatment of severe asthma symptoms and chronic obstructive pulmonary disease. In this work, it was the first time to develop a green and environment friendly ultra-performance liquid chromatographic method using design expert program for the analysis of the three drugs in their combined dosage form. Also, the method was bioanalytically validated for the analysis of the three drugs in spiked human plasma samples. The method was linear in range from 0.50 to 100.0 μg mL−1 for indacaterol and mometasone and from 1.0 to 150.0 μg mL−1 for glycopyrronium. It showed high accuracy where, the % recovery for indacaterol, glycopyrronium and mometasone in plasma were ranged from 94.27 to 97.86%, 96.43 to 98.75% and 96.86 to 98.43%, respectively. Also, it was precise where, the % relative standard deviation for the inter-day precision was ranged from 2.571 to 3.484%, 3.180 to 4.123% and 3.150 to 3.984% and the intra-day precision was ranged from 2.351 to 3.125%, 2.512 to 3.544% and 2.961 to 3.983% for indacaterol, glycopyrronium and mometasone, respectively. The limit of detection and the limit of quantification for indacaterol and mometasone were 0.03 and 0.10 μg mL−1 while for glycopyrronium, they were 0.16 and 0.50 μg mL−1. Highlights Analytical quality by design and green chemistry combined approach. Analytical quality by design using central composite design model for the optimization of the chromatographic conditions with the least number of runs. The first developed RP-UPLC green method for the simultaneous determination of indacterol, glycopyrronium and mometasone. The method was applied for their analysis in spiked plasma samples and combined dosage form. The method greenness was determined by analytical eco-scale. [ABSTRACT FROM AUTHOR]

Background Biologics are essential in cancer treatment because they stimulate the body's natural response to fight cancer, but they are expensive. Biosimilars are more affordable compared to patent biologicals, but it must be verified that they are as effective as their innovators. Characterization of biosimilars and assessment of interchangeability requires many data points for verification. Objective The proposed study provides a quality assessment of two new bevacizumab (BVZ) biosimilars, produced by Amgen and Biocad, Inc. through the development and greenness assessment of an orthogonal testing protocol and purity indicating assay, including size-exclusion (SE-HPLC), reversed-phase (RP-HPLC), and cation exchange chromatography (CEX-HPLC) in addition to dynamic light scattering (DLS) and sodium dodecyl sulfate-polyacrylamide gel electrophoresis (SDS-PAGE). Methods SE-HPLC method was performed and validated to screen the BVZ monomer and its aggregates and/or fragments. Peak purity and system suitability parameters were calculated. Results indicate that the orthogonal protocol is a useful tool for assessing monoclonal antibody stability. It is a key criterion for biosimilarity assessment. DLS and SDS-PAGE results were compared to each other to reveal close retention times and banding patterns between BVZ innovator and its biosimilars. These results showed that Avastin® and the investigated biosimilars have the same profile in terms of peak area of related compounds within the acceptance limit and apparent molecular weight, and the SDS-PAGE technique was found to be the most eco-friendly technique among others. Conclusions The results obtained highlighted the importance of assessing similarities and differences in ensuring the biosimilarity and interchangeability of the studied products. Highlights BVZ is one of the essential monoclonal antibodies in the treatment of colorectal cancer (CRC). BVZ biosimilars were evaluated by developing an orthogonal testing protocol and a purity-indicating assay. The size-exclusion (SE)-HPLC method was applied and validated to monitor the BVZ monomer and its aggregates. The results demonstrated the importance of assessing the stability and biosimilarity of BVZ. [ABSTRACT FROM AUTHOR]

Two selective stability-indicating procedures were adopted for the quantification of Solifenacin succinate (SOL) along with its acid degradant, in its powder form or in pharmaceutical tablet. Under stress conditions, the acid degradation pathway of SOL was investigated, its official impurity (SOL imp-A) was obtained as the possible acid degradation product, also. A densitometric technique based on the separation of SOL from SOL imp-A employing HPTLC plates prelaminated with silica gel 60 F254 as the stationary phase and a developing solution containing methanol:chloroform:ammonia (8:1:1, v/v/v) and UV scanning of the developed bands at 220 nm. Linear regression analysis data for the calibration plot of SOL showed perfect linear relationships throughout the range of concentration 10–60 μg/band. A reversed phase C18 analytical column (4.6 × 250 mm, 5 μm) was also used to separate the mixture at a flow rate of 1 mL/min, using acetonitrile:0.05 M phosphate buffer (70:30, v/v) as the mobile phase and phosphoric acid to set pH = 3.5. Quantification was obtained at 220 nm using peak area and linear calibration curve across a concentration range of 10–70 μg/mL. The recommended procedures were applied to the existing dosage form, and they generated satisfactory results. [ABSTRACT FROM AUTHOR]