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Journal of Applied Pharmaceutical Research
Published by Creative Pharma Assent
ISSN : -     EISSN : 23480335     DOI : 10.18231
Core Subject : Health,
Medicine & Pharmacology
Journal of Applied Pharmaceutical Research (JOAPR) is an official publication of Creative Pharma Assent (CPA). It is an open access, peer review online international journal. JOAPR is primarily focused on multiple discipline of pharmaceutical sciences (Pharmaceutics, Pharmaceutical Technology, Biopharmaceutics, Cosmetic Technology, Pharmacokinetics, Pharmaceutical/Medicinal Chemistry, Computational Chemistry and Molecular Drug Design, Pharmacognosy and Phytochemistry, Herbal drugs/ formulations, Pharmacology, Pharmaceutical Analysis, Pharmacy Practice, Clinical and Hospital Pharmacy, Cell Biology, Genomics and Proteomics, Pharmacogenomics, Bioinformatics and Biotechnology of Pharmaceutical Interest) which publish quarterly. JOAPR also includes evaluation of pharmaceutical excipients & their practical application to research & industry based efforts. The aim of the scientific journal, JOAPR is to present a wide area for the current researchers to share their noble works and ideas in terms of the research papers, review articles and short communications. JOAPR only publish the original research works with a definite innovation and novelty after thorough reviewing. The paper must have a suitable and proper scientific background.
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Articles 12 Documents
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Search results for , issue "Vol. 12 No. 3 (2024)" : 12 Documents clear
Optimizing irbesartan spherical agglomerates through principal component analysis and experimental design Gorde, V. D.; Rachh, Punit R.; Mankar, S. D.; Amin, Saurin
Journal of Applied Pharmaceutical Research Vol. 12 No. 3 (2024)
Publisher : Creative Pharma Assent

Show Abstract | Download Original | Original Source | Check in Google Scholar | DOI: 10.69857/joapr.v12i3.581

Abstract

Background: This study explores the amalgamation of crystallization and agglomeration through spherical crystallization, aiming to develop the spherical crystals of Irbesartan with improved micromeritic properties. The main objective is to use spherical crystallization techniques to improve the micromeritic characteristics of Irbesartan, which has poor flow and compressibility because of its crystal habit. Methodology: A solvent change approach was utilized to synthesize spherical agglomerates of Irbesartan. Several system parameters, including the amount of bridging liquid, the rate of stirring, and the concentration of the polymer, were tuned to enhance the particle size distribution and mechanical qualities. SEM, GC, PXRD, DSC, and FTIR analyses characterised the spherical crystals. Result and Discussion: The study demonstrated that spherical crystallization significantly enhanced Irbesartan's micromeritic properties. The angle of repose of optimized agglomerates was reduced by around 52%, indicating improved considerably flowability of irbesartan. The sphericity of the crystals was validated by SEM examination (shape factor: 0.996), and the solvent levels were found to be within allowable bounds by GC analysis. PXRD data showed no polymorphism alterations, and DSC/FTIR analyses confirmed that the excipients and drug were compatible. Conclusion: This process provides a feasible alternative to classic granulation and agglomeration procedures, resulting in better flow, compressibility, and spherical crystals. It streamlines the Irbesartan formulation, improving efficiency and uniformity, reducing manufacturing costs, higher tablet consistency, and enhancing patient compliance.
Systematic approach to develop and validate High Performance Liquid Chromatographic method for efavirenz and its degradants Sahoo, Sudhir Kumar; Choudhury, Prasanta Kumar; Murthy, P N; Mishra, Uma Shankar; Bisoyi, Saroj Kanta; Kumar , Lokesh
Journal of Applied Pharmaceutical Research Vol. 12 No. 3 (2024)
Publisher : Creative Pharma Assent

Show Abstract | Download Original | Original Source | Check in Google Scholar | DOI: 10.69857/joapr.v12i3.586

Abstract

Background: The crucial aspect to consider during method development and validation, ensuring accurate, precise, and specific estimation of drug substances and drug products, is stability. Various factors, including environmental, instrumental, reagent, and human factors, can pose challenges in achieving suitable method development and validation. Objective: This work aimed to develop and validate a low flow rate, LCMS compatible, simple, and rapid reverse-phase high-performance liquid chromatographic method for estimating efavirenz and its degradation products at different stress conditions. Materials and Methods: The HPLC system employed a Phenomenex Luna 5μ C18 (2) 100A (250 x 4.6 mm) column and a mobile phase of methanol: 20 millimolar ammonium formate solution (90:10) adjusted to pH 4 with formic acid. All analytes were separated within 15 minutes and detected at 247 nm. Method validation was carried out according to ICH guidelines, including linearity, accuracy, precision, ruggedness, robustness, LOD, and LOQ. Results and Discussion: The method was linear in the 10-90 μg/ml range, with a regression coefficient 0.999. Intra- and inter-day precisions, ruggedness, and robustness were within acceptable limits (≤2% RSD) with LOD and LOQ of 0.35 and 1.16 μg/ml, respectively. Degradation study indicates well resolution of the drug and degradants.  Conclusion: Purposeful degradation of efavirenz resulted in different degradation products under various stress conditions, and the method demonstrated satisfactory resolution from its degradants.

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