Method validation
12 articles · search the full text for this term
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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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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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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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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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Authentication of a Rapid RP-HPLC technique for Quantification of Remogliflozin and Metformin in Medicinal Formulations
Abstract: A new, precise, and stability-assessing advanced liquid chromatography (HPLC) technique for simultaneous quantification of Remogliflozin and Metformin in fixed dose pharmaceutical formulations was designed and verified. Optimization of the technique was carried out on flowing phase composed of ethanenitrile and buffer, under isocratic conditions, the resolution of peak being sharp with retention times of 3.24 min and 4.89 min for Remogliflozin and Metformin, respectively. Technology suitability was confirmed by the …
Published in Trends in Drug Delivery · Vol. 12, Issue 2, 2025 · pp. 70–77 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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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 method for simultaneous determination of Drospirenone and Ethinylestradiol in Bulk and their Pharmaceutical dosage form
Abstract: Oral contraceptive is used to prevent the pregnancy which is contain hormones to block the release of eggs from the ovaries. Most of them contain estrogen and progesterone. Nowadays, usage of hormonal contraceptive is sharply enhancing; around 100 million of women worldwide are taking these drugs. With this drug fertility rate can be supressed as long as they want or plan their activity along with these drugs provide efficacy, reliability, …
Published in Trends in Drug Delivery · Vol. 11, Issue 3, 2024 · pp. 46–67 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 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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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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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