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Gut microbiota and infectious diseases affect neurological disorders, brain development, and function. Compounds generated in the gastrointestinal system by gut microbiota and infectious pathogens may mediate gut-brain interactions, which may circulate throughout the body and spread to numerous organs, including the brain. Studies shown that gut bacteria and disease-causing organisms may pass molecular signals to the brain, affecting neurological function, neurodevelopment, and neurodegenerative diseases. This article discusses microorganism-producing metabolites with neuromodulator activity, signaling routes from microbial flora to the brain, and the potential direct effects of gut bacteria and infectious pathogens on brain cells. The review also considered the neurological aspects of infectious diseases. The infectious diseases affecting neurological functions and the disease modifications have been discussed thoroughly. Recent discoveries and unique insights in this perspective need further validation. Research on the complex molecular interactions between gut bacteria, infectious pathogens, and the CNS provides valuable insights into the pathogenesis of neurodegenerative, behavioral, and psychiatric illnesses. This study may provide insights into advanced drug discovery processes for neurological disorders by considering the influence of microbial communities inside the human body. [ABSTRACT FROM AUTHOR]

Microorganisms such as fungi and bacteria are prosperous producers of secondary metabolites; moreover, they are home to a large number of silent biosynthetic gene clusters, but they are all poorly expressed. Thus, these resultant compounds remain cryptic or unknown. However, since these cluster products have many bioactivities, stimulating their production and gaining access to their related structures are considered a top priority. Here, we summarize the three strategies that have been the topic of current trends. Regulating of genetic investigation, heterogeneous and refactoring cluster expression, as well as elicitor and coculture screening are the strategies utilized to unlock the expression of biosynthetic gene clusters (BGCs). These all help to triggers the manufacturing of innovative metabolites having various functions. [ABSTRACT FROM AUTHOR]

Background: The future of smart factories and pharmaceutical industries has evolved significantly since the 19th century. Computers have been used in the pharmaceutical field since the 1980s with the emergence of Artificial Intelligence (AI). In addition, automation and robotics are used in the pharmaceutical industry to improve the efficiency of pharmaceutical development and production. Purpose: The present review article covers the future roles of AI, automation and robotics in pharmaceutical industries. Methodology: The current review article employed a comprehensive search strategy across relevant databases, including PubMed, Scopus and Web of Science, utilizing keywords such as AI, Automation, Robotics and Pharmaceutical Industries. The articles considered a focus on recent advancements and emerging trends in the intersection of AI, automation and robotics within pharmaceutical sectors. Results: AI, incorporating predictive machine learning and reasoning techniques, aids in the preclinical identification of molecules and forecasting potential lead compounds before conducting clinical trials. automation offers significant benefits in monitoring and predictive maintenance of production lines, power distribution and control machines. Robotic process automation improves efficiency by connecting computer terminals to handle various manufacturing process elements. Conclusion: Artificial intelligence, automation and Robotics have sparked innovations in the healthcare business, benefiting the global ecosystem and healthcare delivery. Incorporating these advanced tools in pharmaceutical industries from raw material selection to final product development could improve the quality and safety of the pharmaceutical products and reduce the time and cost. [ABSTRACT FROM AUTHOR]

Spironolactone is one of the non‐selective mineralocorticoid receptor antagonists acting as anti‐diuretic drugs. Spironolactone is reported to possess mild to severe hyperkalemia which could often result in fatal conditions. Although several analytical methods for evaluating spironolactone as tablet dosage forms have been established in human biological systems, it is crucial to highlight that these approaches are still limited to the suspension dosage form. In this study, we have quantified spironolactone suspension in human plasma with an efficient, sensitive, and optimized ultra‐performance liquid chromatography (UPLC)‐tandem mass spectrometry‐based bioanalytical method using a deuterated internal standard method. A reverse phase UPLC analysis and mass spectrometric detection was performed using electrospray ionization in positive ion mode as an interface, and multiple reaction monitoring as a mode of acquisition. The retention of Spironolactone (SL) and Spironolactone d7 (SL‐d7) was found to be around 6.15 and 6.07 min, respectively. The linearity range was 1.007–100.224 ng/mL for SL with 0.1 mL sample volume. The method was successfully applied to the pharmacokinetic study of spironolactone in healthy male volunteers by administrating 25 mg/5 mL oral suspension and is in accordance with bioanalytical guidelines. [ABSTRACT FROM AUTHOR]

Malnutrition remains a major global issue-affecting people of all ages. Iron deficiency is one of the existing malnutrition deficiencies limiting long-term human development. Food-based interventions play a vital role in the growth, development (physical and cognitive), and socioeconomic status of an individual. Several food-based approaches (viz., fortification and bio fortification of staple foods) have been employed for improving malnutrition in vulnerable populations. In underdeveloped countries, staple foods like rice, wheat, beans, and pearl millets etc. are being actively fortified and bio fortified to enhance the iron content intended to deliver the required nourishment with optimal consumption. However, translational iron levels from functional foods may not be proportional to iron absorbed into systems. Considering the effectiveness of bioavailability, additional emphasis is required in establishing the same for the functional foods which could serve as an effective alternative to existing methods in mitigating iron malnutrition. This review emphasizes the importance of iron, iron physio-pathological, and the current status of food strategies in dealing with iron malnutrition. [ABSTRACT FROM AUTHOR]

This study employed the response surface methodology to optimize the extraction conditions for recovering vitamins D2 and K1 from green leafy vegetables using ultrasonication-assisted extraction. The vitamin content was determined using an Accucore C18 column and a UPLC-Q-ToF/MS method. An RSM-I-Optimal design was used for designing the experiment to find the best combination of solvent level (mL), sonication time (min), sonication frequency (kHz), and temperature (°C). The experimental data from a 25-sample set were fitted to a second-order polynomial equation using multiple regression analysis. The extraction models had R2 values of 0.895 and 0.896, respectively, and the probability values (p < 0.0001) indicated that the regression model was highly significant. The optimal extraction conditions were: solvent level of 65 mL, sonication time of 45 min, sonication frequency of 70 kHz, and temperature of 45 °C. Under these conditions, the predicted recovery (%) values for vitamins D2 and K1 were 90.7% and 90.4%, respectively. This study has the potential to use the reported extraction method for routine quantification of vitamins D2 and K1 in the laboratory using UPLC-Q-ToF/MS. [ABSTRACT FROM AUTHOR]

A bioanalytical method for the quantification of rosiglitazone in rat plasma and tissues (adipose tissue, heart, brain, bone, and kidney) using LC–MS/MS was developed and validated. Chromatographic separation was achieved on a Gemini C18 column (50 × 4.6 mm, 3 μm) using a mobile phase consisting of 10 mM ammonium formate (pH 4.0) and acetonitrile (10:90, v/v) at a flow rate of 0.8 mL/min and injection volume of 10 μL (internal standard: pioglitazone). LC–MS detection was performed with multiple reaction monitoring mode using target ions at m/z → 358.0 and m/z → 357.67 for rosiglitazone and pioglitazone (internal standard), respectively. The calibration curve showed a good correlation coefficient (r2) over the concentration range of 1–10,000 ng/mL. The mean percentage recoveries of rosiglitazone were found to be over the range of 92.54–96.64%, with detection and lower quantification limit of 0.6 and 1.0 ng/mL, respectively. The developed method was validated per U.S. Food and Drug Administration guidelines and successfully utilized to measure rosiglitazone in plasma and tissue samples. Further, the developed method can be utilized for validating specific organ‐targeting delivery systems of rosiglitazone in addition to conventional dosage forms. [ABSTRACT FROM AUTHOR]

This article discusses the importance of identifying and quantifying synthetic impurities in herbal medicines and dietary supplements. It highlights the need for specific and novel analytical methods to detect these impurities, which are often used to adulterate herbal products. The article explains the concept of synthetic analogues, which are chemical compounds that closely resemble natural compounds but have slight differences in structure and properties. It also mentions the limitations of current analytical techniques and proposes the use of innovative methods such as reverse-phase HPLC for the identification and characterization of synthetic impurities. The article concludes by emphasizing the significance of these analytical methodologies in addressing issues related to natural product adulteration and ensuring quality control. [Extracted from the article]

In the present analytical approach, beta-alanine (ALA) and tris-(hydroxyl methyl) aminomethane (TRIS) were investigated as peak modifiers due to their water solubility and their possible peak modifying a property. These reagents were tested for their efficacy on the elution of aceclofenac (ACF) and haloperidol hydrochloride (HLC) from C18 column (250 mm × 4.6 mm, 5 μ) equipped with a photodiode array detector. The test reagents were investigated at 0.25 ± 0.05% concentration with a varying % aqueous composition on elution efficacy of HLC and ACF. The added ALA/TRIS in the mobile phase significantly (P  < 0.05) improvised the symmetrical elution of HLC with 3-fold theoretical plates increase (P  < 0.05) and 10-fold reduced capacity factor as compared to the control run. For ACF, the shoulder effect observed for ACF peak was eliminated. The optimized mobile phase was a combination of acetonitrile and water containing 0.25% beta-alanine/TRIS (pH 3.5 with ortho-phosphoric acid) at the ratio of 70:30 and 60:40% v/v, respectively, for ACF and HLC. The method was validated as per ICHQ2 guidelines. The column performance was tested for reproducibility in non-peak modifier applications and revealed a null effect on the column, thus these agents are relatively less toxic to HPLC columns. [ABSTRACT FROM AUTHOR]

Considering the importance of robust analytics in the pharmaceutical industry, an analytical quality by design (AQbD) based reversed phase liquid chromatographic method was developed for the quantification of propranolol hydrochloride (PRO) and etizolam (ETZ). The developed method was validated and compared with an analytical method of conventional approach. In AQbD approach, analytical target profile (ATP) and risk assessment were tailored to identify critical method variables (CMVs) as inputs. Accordingly, pH (X1) % aqueous composition (X2), flow rate (X3) and % triethylamine (X4) were identified as CMVs and the respective retention time (Y1 and Y2) and theoretical plate (Y3 and Y4) for PRO and ETZ were set as method responses. The central composite design (CCD) predicted the scientific relationship between CMVs (Xn) and method responses (Yn). Then, the method operable design region (MODR) was arrived from systematic simulation and contour plots. There were six candidate methods selected from MODR and they demonstrated the r2 value > 0.9, thus the model proved its consistency for prediction. The robust range for the selected CMVs was derived from MODR, thus the ranges were 3–4 for pH, 30–35 for % aqueous composition, 0.9–1.1 mL min−1 for flow rate and 0.1–0.2 for % TEA buffer. Finally, the target AQbD method was optimized with pH; 3.5 (X1), 30% of aqueous composition in mobile phase with acetonitrile (X2), 0.9 mL min−1 of flow rate of (X3) and 0. 15% trimethylamine as buffer (X4) and further validated as per ICH Q2 guidelines. The result was compared with the conventional LC method with respect to specificity, accuracy, precision and robustness. The conventional HPLC method failed for robustness and showed relatively higher % RSD values than AQbD method. [ABSTRACT FROM AUTHOR]

Back Ground: Efavirenz is a non-nucleoside reverse transcriptase inhibitor (NNRTI) used for the first-line treatment of AIDS. Objective: The aim of the present study is to develop and validate a simple, specific, accurate, precise and linear reverse-phase high performance liquid chromatographic method for the determination & the quantification of Efavirenz in bulk drug as well as in pharmaceutical formulations. Method: The RP-HPLC method consists of Shimadzu Shim-Pack RP-HPLC column (150mm x 4.6mm, i.d. 5μm) as stationary phase with the mobile phase of 20mM ammonium acetate (pH 3.5): acetonitrile (30:70% v/v) at a flowrate of 0.8ml/min with elution wavelength at 247nm. Result: In this developed method the retention time of Efavirenz was 6.225 ± 0.2min. The linearity of Efavirenz comes at the range of 200-600ng/ml with R2 >0.99. The precision of the developed method was calculated by the Relative Standard Deviation and the result was found to be <2%. The percent recovery was observed between the ranges (98-101%) of which represent the accuracy of the method. The limit of detection and the limit of quantification are 5ng/ml and 15ng/ml respectively. Conclusion: A simple, specific, precise, accurate, rapid and linear RP-HPLC method has been developed and validated for the estimation and quantification of anti-retroviral drug (Efavirenz) in bulk drug as well as in pharmaceutical formulations as per ICH Q2 (R1) guidelines. This developed and validated method can further be used for the routine analysis of Efavirenz in various pharmaceutical industries & in Bioequivalence & Bioavailability studies. [ABSTRACT FROM AUTHOR]

Objectives: The aim of this present study is to develop an accurate, precise and linear Reverse-phase High-performance Liquid Chromatographic (RPHPLC) method for the estimation of raltegravir potassium in the bulk and pharmaceutical dosage form. Methods: The chromatographic system employs a reverse phase shim-pack C18 column, (150 x 4.6 mm; 5 µ) using the mobile phase acetonitrile: (0.05 M) ammonium acetate buffer, (pH -4 adjusted with glacial acetic acid) in the proportion of 50:50 v/v, delivered at a flow rate of 0.8 ml/min with the detection wavelength of 271 nm. Results: The developed method resulted in the retention of raltegravir at 4.31 min. Raltegravir potassium exhibited linear relationship (r2> 0.9999) over the analytical range 10-50 µg/ml. The precision was exemplified by a relative standard deviation of 1.60%. The percentage recovery was found to be in the range of 100-102%, during accuracy studies. The Limit of Detection (LOD) and Limit of Quantitation (LOQ) was found to be 0.104 µg/ml and 0.315 µg/ml, respectively. Conclusion: An accurate, precise and linear RP-HPLC method was developed and validated for the quantitative estimation of raltegravir potassium in (20 mg, 50 mg) tablet as per ICH guidelines and hence it can be used for the routine analysis in various pharmaceutical industries. [ABSTRACT FROM AUTHOR]

Background Glutathione, silybin, and curcumin are well-known potential antioxidants that are recommended as adjuvant therapy in cancer treatment. Objective Based on the principles of Analytical Quality by Design (AQbD) and green analytical chemistry, a simple, robust, and environmentally benign HPLC method for the simultaneous estimation of glutathione, silybin, and curcumin in bulk and formulation was performed. Method Elution was achieved by an Agilent Eclipse XDB C18 (150 mm × 4.6 mm id, 3.5 μm) column using a gradient mobile phase composed of ethanol–water pH 6.7 (with 0.1%, v/v orthophosphoric acid) and 1.07 mL/min flow rate with PDA detection at 215 nm. Critical method variables were identified by risk assessment using an Ishikawa diagram, and multivariate optimization of the experimental conditions for the HPLC technique was accomplished by central composite design using design of experiments (DoE) software. Results The separation was achieved within 15 min, where the retention time of glutathione, silybin, and curcumin were 3.3, 4.9, and 7.3 min, respectively. The standard curve was linear in the range of 3.75–26.25 µg/mL for glutathione, 62.50–437.50 µg/mL for silybin, and 12.5–87.50 µg/mL for curcumin. The developed method was validated as per ICH guidelines Q2 (R1), and all the parameters are within specified limits. Conclusions The proposed method is simple, precise, and robust, which can be employed for routine analysis and also concluded to be a greener approach according to AGREE, Green Analytical Procedure Index, and analytical eco-scale tools. Highlights The chosen antioxidants were evaluated for the very first time simultaneously using the chromatographic technique in bulk and dosage forms employing green solvents. The peak purity of all three compounds was studied using a PDA detector. Wastage was reduced in terms of time, cost, and solvents by employing AQbD elements and tools. Complete application of environmentally sustainable safe solvents were employed. [ABSTRACT FROM AUTHOR]

This study aims to examine the impact of globalization on private higher education in Malaysia. The impact of globalization and the development of knowledge-based economy have caused much dramatic change to the character and functions of higher education in Malaysia. The major trend is the reforming and restructuring of private higher education in Malaysia to make it more competitive globally. Malaysia and many of the Asia Pacific countries are promoting higher education to the world. However, criticism from world educational councils have highlighted that the impact of globalization on higher education in Asia Pacific countries to follow the ideologies and global practices without developing their own unique systems and disregarding their rich tradition and cultures. [ABSTRACT FROM AUTHOR]

Feruloyl Methane (FM) is a common impurity in Synthetic Curcumin (SC) that affects its purity and potency. The identification and quantification of FM is crucial to ensure the quality and safety of SC based drugs. The current study aims to develop and validate a simple, rapid and cost-effective analytical technique for the precise and accurate quantification of FM in SC using RP-HPLC with a UV-Vis detector (Ultraviolet/Visible) and assessment of its toxicity by multi-computational methods. The developed HPLC method with a UV-Vis detector enabled accurate identification and quantification of FM in SC. The optimized method was validated in accordance with ICH guidelines Q2(R1) and all parameters were found to be within the standard acceptance range. The ideal run time was determined to be 10 min and the impurity eluting at a retention time of 2.65 min was characterized using spectral techniques viz., mass spectrometry, FTIR and 1 H NMR, confirming the presence of FM. The amount of FM in SC was estimated to be 8.26 µg/kg. In addition, toxicity assessments using in silico tools such as ProTox- II, ADMETlab 2.0 and PASS Online indicated that the presence of FM in SC is not safe for human consumption. In conclusion, the developed method is not only capable of quantifying FM but also aids in distinguishing Natural Curcumin (NC) adulterated with SC and can be applied to a wide range of fields such as natural drug analysis, food analysis and toxicity prediction. [Display omitted] • Herbal products lack proper drug approval processes for safety and efficacy validation. • Lack of analytical methods leads to products being released without proper analysis. • Impurities in synthetic compounds differ from those in natural products. • Synthetic curcumin impurities aid in detecting adulteration of natural curcumin. • In silico toxicity studies aid in the safety evaluation of synthetic impurities. [ABSTRACT FROM AUTHOR]

A rapid, selective, and reliable LC-MSn method has been developed and validated for the isolation and structural characterization of the degradation product of darunavir (DRV). DRV, an HIV-1 protease inhibitor, was subjected to intrinsic oxidative stress conditions using 30% hydrogen peroxide and the degradation profile was studied. The oxidative degradation of DRV resulted in one degradation product. The unknown degradation product was separated on a Hibar Purospher Ci8 (250 mm x 4.6 mm; 5 pm) column by using 0.01 M ammonium formate (pH 3.0) and acetonitrile as mobile phase in the ratio of 50:50, v/v. The eluents were monitored at 263 nm using a UV detector. The isolated degradation product was characterized by UPLC-Q-TOF and its fragmentation pathway was proposed. The proposed structure of the degradation product was confirmed by HRMS analysis. The developed stability-indicating LC method was validated with respect to accuracy, precision, specificity/selectivity, and linearity. No prior reports were found in the literature about the oxidative degradation behavior of DRV. [ABSTRACT FROM AUTHOR]