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686 articles for “Validation”
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A Comprehensive Exploration of Method Validation and Development in Pharmaceutical Analysis: Focus on Vortioxetine Analysis
Abstract: The pharmaceutical industry relies on rigorous method validation to ensure the accuracy, precision, and reliability of analytical techniques employed in drug testing and quality control. This comprehensive exploration delves into the validation parameters and guidelines essential for method validation, emphasizing accuracy, precision, linearity, detection and quantitation limits, specificity, range, robustness, and ruggedness. Validation plays a pivotal role in guaranteeing high-quality products, adhering to good manufacturing practices (GMP), and optimizing manufacturing …
Published in Research & Reviews: A Journal of Drug Formulation, Development and Production · Vol. 11, Issue 1, 2024 · pp. 46–52 Read article
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Comprehensive Overview of Analytical Chemistry: Principles, Techniques, and Method Validation
Abstract: Analytical chemistry constitutes a vital discipline within the realm of scientific inquiry, facilitating the identification and measurement of components present in diverse substances and mixtures. This paper delineates the principles, methodologies, and applications of analytical chemistry, focusing on spectroscopy and chromatography techniques. Spectroscopy, including UV-Visible spectroscopy, elucidates molecular properties by analysing the absorption of electromagnetic radiation, while chromatography enables the separation of compound mixtures based on differential affinities to stationary …
Published in Research and Reviews: A Journal of Pharmaceutical Science · Vol. 15, Issue 1, 2024 · pp. 14–21 Read article
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UV Method of Development and Validation of Olaparib
Abstract: An analytical method must be developed and validated in the discovery, development, and production of pharmaceuticals to ensure the identification, purity, potency, and performance of drug commodities. Quality control laboratories use official test protocols that emerge from the processes. A simple ultraviolet spectrophotometric approach was designed and validated using various characteristics, including linearity. Precision, reproducibility, accuracy, robustness, ruggedness, limit of detection, and limit of quantification are among the measuring criteria. …
Published in Research and Reviews: A Journal of Pharmaceutical Science · Vol. 15, Issue 2, 2024 · pp. 20–27 Read article
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HPTLC Method Development and Validation for Rabeprazole Sodium in Pharmaceutical Formulation
Abstract: Background: The most common medication for acid related disorders stands as Proton pump inhibitor (PPI) Rabeprazole Sodium. The pharmaceutical formulations require essential quality control of Rabeprazole Sodium through reliable analytical methods to maintain reliability. HPTLC provides a cost-effective rapid method for drug quantification compared to conventional HPLC methods so how HPTLC stands as an appropriate method for drug determination. Objective: The emphasis of this research project involves developing and validating …
Published in Research and Reviews: A Journal of Pharmaceutical Science · Vol. 16, Issue 2, 2025 · pp. 18–24 Read article
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Experimental Validation and Implementation Framework for Optimized Methane Yield Prediction in Anaerobic Digestion
Abstract: The correct validation and realistic application of optimized anaerobic digestion (AD) models are essential steps in transferring biogas production systems to real-life. This paper outlines an experimental validation and deployment pipeline of an AI-optimized model of the methane yield prediction model based on the application of more advanced machine learning and Bayesian optimization methods. Others The validated surrogate-assisted optimization model was tested with controlled laboratory-scale AD experiments at optimized operating …
Published in International Journal of Environmental Noise and Pollution Control · Vol. 4, Issue 1, 2026 · pp. 25–32 Read article
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Development and Validation of a Robust RP-HPLC Method for Rufinamide Quantification in Pharmaceutical Dosage Forms
Abstract: The creation and validation of a simple, precise, and targeted reverse phase high-performance liquid chromatographic (RP-HPLC) approach allowed for the quantification of rufinamide in pharmaceutical dosage forms. With a mobile phase of methanol and water (50:50, v/v), the technique used a gradient mode Symmetry Qualisil gold C18 column (4.6 x 150mm, 5 μm). For the detection method, a flow rate of 1 mL/min was employed at 220 nm. During a …
Published in Emerging Trends in Personalized Medicines · Vol. 1, Issue 1, 2024 · pp. 25–32 Read article
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A Comprehensive Review of Analytical Method – Development and Method Validation of Digoxin Tablets
Abstract: The main objective of this review is to give an outline of the method development and validation process of digoxin, and this review covers the different types of spectroscopic and chromatographic techniques, such as HPLC, UHPLC-Tandem mass spectroscopy, TLC, and LC-MS. A novel method for the determination of digoxin in biological samples has been developed and validated, focusing on improving sensitivity, specificity, and reproducibility. The method was validated in terms …
Published in Research & Reviews: A Journal of Drug Formulation, Development and Production · Vol. 12, Issue 1, 2025 · pp. 47–58 Read article
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Bioanalytical Method Development and Validation for the Estimation of Levothyroxine in Human K₃EDTA Plasma by Using UPLC-MS/MS
Abstract: A rapid, sensitive, and highly selective UPLC-MS/MS method was developed and validated for the quantitative estimation of Levothyroxine in human plasma using Levothyroxine-D₃ as the internal standard (IS). Chromatographic separation was achieved on a Gemini NX-C18 column (50 × 3.0 mm, 3 µm) with a mobile phase consisting of acetonitrile and water (70:30, v/v) containing 0.015% formic acid at a flow rate of 0.5 mL/min. The total run time was …
Published in Research & Reviews: A Journal of Drug Formulation, Development and Production · Vol. 12, Issue 3, 2025 · pp. 32–46 Read article
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Analytical Method Development and Validation of Simultaneous Estimation of Natural Active Constituents Andrographolide and Piperine by UV Method.
Abstract: A simple, accurate, precise, and robust UV-Visible spectrophotometric method was developed and validated for the simultaneous estimation of Andrographolide and Piperine in bulk and combined pharmaceutical dosage forms. Preformulation studies confirmed favorable physicochemical properties for both drugs, including acceptable solubility profiles, melting points, pH values, and partition coefficients. The method development involved determination of λmax values at 224 nm for Andrographolide and 288 nm for Piperine using ethanol as solvent. …
Published in Research & Reviews: A Journal of Pharmacognosy · Vol. 12, Issue 3, 2025 · pp. 33–41 Read article
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A Systematic Review of Method Development and Validation for Ramipril Analysis Using Hplc in Cardiovascular Research
Abstract: The field of analytical chemistry encompasses a variety of methods that are crucial in determining the chemical composition of different substances. UV-visible spectroscopy and high-performance liquid chromatography (HPLC) are two widely utilized methods that are the subject of this article. UV-visible spectroscopy uses the Beer-Lambert law to quantify light absorption, which can provide information about the concentration of absorbing species. The method is based on how light and matter interact, …
Published in Journal of Modern Chemistry & Chemical Technology · Vol. 15, Issue 2, 2024 · pp. 37–44 Read article
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A New Separation Technique for Method, Development and Validation of Aclidinium Bromide and Formoterol Fumarate in Its Pure and Pharmaceutical Dosage Form by Using Rp-HPLC
Abstract: A new simple, precise, selective and accurate, a new method of development and validation using Rp-HPLC for the estimation of Aclidinium bromide and Formoterol Fumarate in its pure and pharmaceutical dosage form. Chromatogram was run through DIKMA Spursil, C18 segment (4.6×150 mm, 5µ0). Mobile phases contain 0.1% OPA: Acetonitrile (30:70) with the use of the 0.1% OPA buffer, stream rate of 1 ml/min and measured in 280 nm. The run …
Published in Research and Reviews: A Journal of Pharmaceutical Science · Vol. 15, Issue 3, 2024 · pp. 18–36 Read article
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A Review of Analytical Method Development and Validation of Amiodarone Pharmaceutical Dosage Form
Abstract: The review provides an in-depth analysis of the analytical method development and validation process for amiodarone tablets. Method validation is crucial in the pharmaceutical industry for ensuring the quality and efficacy of tablets, as it ensures the accuracy, precision, and reliability of analytical techniques used in drug testing. It is a prerequisite for method development, adhering to good manufacturing practices, and optimizing processes. This review aims to consolidate and analyse …
Published in Research & Reviews: A Journal of Drug Formulation, Development and Production · Vol. 12, Issue 1, 2025 · pp. 59–71 Read article
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RP-HPLC Analytical Method Development and Validation for Quantitative Estimation of Metoclopramide Hydrochloride in Solid Oral Formulations
Abstract: RP-HPLC technique formulated for the numerical assessment of Metoclopramide Hydrochloride in tablet formulation has been confirmed for reliability. A C18 column facilitated the chromatographic separation using a mobile phase comprising 60:40 (v/v) potassium dihydrogen phosphate buffer: meth anol mixture. Such method was used to detect, where the retained time was 6.78 minutes and Metoclo pramide Hydrochloride produced a clear peaked at 273 nm. Results were in agreement with ICH Q2 …
Published in Research & Reviews: A Journal of Drug Formulation, Development and Production · Vol. 12, Issue 2, 2025 · pp. 07–15 Read article
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Analytical Method Development and Validation for Simultaneous Estimation of Paracetamol and Piroxicam by UV Method
Abstract: A new establishment and validation of a simple, precise, accurate and cost effective UV-Visible spectrophotometric method was developed to estimate both Paracetamol and Piroxicam simultaneously in conjoined pharmaceutical dosage forms. This technique was founded on simultaneous equation method of absorbances recorded at 252.0 nm and 282.0 nm of Paracetamol and Piroxicam in methanol respectively and an isosbestic point could be observed at 265.0 nm. It showed very good linearity over …
Published in Research & Reviews: A Journal of Drug Formulation, Development and Production · Vol. 12, Issue 3, 2025 · pp. 14–21 Read article
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Codal Validation and Optimization of Gantry Girders Under Variable Wheelbase and Impact Loads: A Review of Analytical, Numerical, and Codal Approaches
Abstract: Gantry girders serve as critical structural elements in industrial facilities such as steel plants, workshops, and heavy manufacturing units, where electric overhead traveling (EOT) cranes operate. The design of these girders is governed by stringent codal provisions to ensure safety under bending, shear, and deflection. However, discrepancies between codal predictions, analytical formulations, and finite element analysis (FEA) results, particularly under variable wheelbase and dynamic impact loads, have been widely reported. …
Published in Journal of Offshore Structure and Technology · Vol. 12, Issue 3, 2025 · pp. 23–29 Read article
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Photochemically Assisted LC–MS Method Development and Validation for Stability-Indicating Determination of Glasdegib in Rat Plasma
Abstract: A simple, precise, and cost-effective LC–MS method was successfully developed for the determination of Glasdegib in rat plasma. The method optimization was carried out by systematically varying key chromatographic parameters, including flow rate, injection volume, analyte concentration, and mobile phase composition, to achieve optimal sensitivity and resolution. A C18 Hypersil BDS column (150 mm × 4.6 mm, 3.5 µm particle size) was used for chromatographic separation, offering effective peak shape …
Published in International Journal of Photochemistry and Photochemical Research · Vol. 4, Issue 1, 2026 · pp. 11–20 Read article
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Lamivudine And Dolutegravir Simultaneous Dosage Forms Determined and Validated Using The RP-UPLC Method
Abstract: RP-UPLC has been used to produce a straightforward, precise, and accurate approach for the simultaneous estimation of dolutegravir and lamivudine in a pharmaceutical dose form. A HSS C18 column of 2.8 x 50 mm and featuring particles with a size of 1.6 μm was used to process the chromatogram. A mixture of 70:30 Buffer Na2HPO4 and methanol made up the mobile phase, which was pushed across the column at a …
Published in Emerging Trends in Personalized Medicines · Vol. 1, Issue 1, 2024 · pp. 5–13 Read article
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Development and validation of a method for simulataneous determination of tenovifir disoproxil fumarate emtriculabine and isonized in bulk and pharmaceutical dosage form using RP-HPLC with relevance to toxicological aspects
Abstract: Hence, proposed analytical methods are simple, novel, economical, rapid, sensitive, reproducible and accurate for the Simultaneous estimation of Tenofovir Disoproxil Fumarate, Emtricitabine and Isoniazid in Bulk and Phamaceutical dosage form by using RP- HPLC. This Method gives reliable assay results with short analysis time using mobile phase of Acetonitrile : 0.02M Potassium Dihydrogen Orthophosphate: water (pH 5.3) in the ratio of 60: 25: 15 respectively. Retention time was found to …
Published in Research and Reviews: A Journal of Toxicology · Vol. 14, Issue 1, 2024 · pp. 17–25 Read article
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Application of pET28a Vector for the Over Expression of Recombinant Human Tim23 Protein in E. coli and its Validation by Immunoblotting
Abstract: This study aimed to produce recombinant human Tim23 protein by molecular cloning, expression, and purification. Amplification of human TIM23 was carried out by polymerase chain reaction (PCR) and cloned into DH5α cells. The pET28a-human TIM23 was transformed into BL21DE3 and expressed the gene by IPTG induction. Recombinant pure human Tim23 antigen was prepared, and injected into rabbits and polyclonal antibodies were raised, which was confirmed by western blotting. The transformed …
Published in Research and Reviews : A Journal of Life Sciences · Vol. 14, Issue 1, 2024 · pp. 32–44 Read article
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Advancements in Method Development and Validation for Levocetirizine: A Comprehensive Review
Abstract: This review article delves into the intricate realm of concurrent estimation of multiple compounds, with a specific emphasis on Levocetirizine and its related substances. It looks into how to improve analytical process specificity by using reverse phase high-performance liquid chromatography (RP-HPLC) in conjunction with UV detection. The study meticulously explores the intricacies of method development and validation, offering invaluable insights into the realms of precision and accuracy within pharmaceutical analysis. …
Published in Research & Reviews: A Journal of Drug Formulation, Development and Production · Vol. 11, Issue 1, 2024 · pp. 15–27 Read article