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All Journal Journal of Applied Pharmaceutical Research
Shorgar, Neetu
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Medicine & Pharmacology

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Quantification of oteseconazole in rat plasma using LC-MS/MS and its application to pharmacokinetic study Susararla, Krishna Phani Chandra; Shelke, Om; Shorgar, Neetu
Journal of Applied Pharmaceutical Research Vol. 12 No. 4 (2024)
Publisher : Creative Pharma Assent

Show Abstract | Download Original | Original Source | Check in Google Scholar | DOI: 10.69857/joapr.v12i4.485

Abstract

Background: Oteseconazole is a new molecule launched for human treatment. However, the information is not available in the public domain for analyzing blood samples. This study describes the method development and validation using LC-MS/MS to measure the concentration of Oteseconazole in rat plasma. Methodology: The analysis method was developed using a phenyl column, which was utilized to accomplish separation. Furthermore, the mobile phase was a combination of acetonitrile and 0.1% formic acid in water, with a ratio of 30:70 (v/v). The sample was introduced into the system at a 1.0 mL/min flow rate, and the injection volume was 10 μLand analyzed for five minutes using mass spectrometer +ESI mode. Results and discussion: MRM is used to quantify Oteseconazole and Posaconazole by analyzing the transitions of their respective m/z values. The concentration ranges of Oteseconazole were 5-100 ng/mL. The correlation coefficient of Oteseconazole was found to be 0. 999. HQC, MQC, LQC, and LLQC precision and accuracy were determined to be 98.60%, 98.69%, 96.11%, and 94.48%, respectively. Respectively, the accuracy recovery of Oteseconazole was determined to be 97.48%. In pharmacokinetic studies, it was observed that Oteseconazole exhibited an average AUC0-t value of 1386 ng-hr/ml and a Cmax value of 44.864 ng/ml in rats. Conclusion: The validated approach has effectively demonstrated the determination of pharmacokinetic parameters after the oral administration of Oteseconazole in Wister rats.
Development of a stability-indicating UPLC method for quantification of mirvetuximab soravtansine-gynx in pharmaceutical formulations using quality by design (QbD) principles Rao, K. V. Umamaheswara; Shorgar, Neetu
Journal of Applied Pharmaceutical Research Vol. 13 No. 2 (2025)
Publisher : Creative Pharma Assent

Show Abstract | Download Original | Original Source | Check in Google Scholar | DOI: 10.69857/joapr.v13i2.977

Abstract

Background: This study intended to introduce a robust ultra-performance liquid chromatography (UPLC) method for quantifying Mirvetuximab soravtansine-gynx (MSG) in pharmaceutical dosage forms. A systematic approach incorporating the Design of Experiments (DoE) was employed to optimize reliable, sensitive, and efficient chromatographic conditions. Methodology: The finalized method utilized a Waters ACQUITY BEH Phenyl (50 mm) Column with a mobile phase comprising acetonitrile and 0.1% aqueous formic acid in 30:70 (v/v) at 0.2 mL/min and 271 nm and PDA wavelength. Results and discussion: The method validation demonstrates excellent linearity (R² = 0.991, p < 0.05) over 17.50–105 µg/mL. The Intraday and interday precision (%RSD) values were 0.568 and 0.544, respectively, confirming method reproducibility. Accuracy was validated through recovery studies, which produced results within the range of 100.1–100.5%, whereas the robustness test highlights the method's resilience to minor variations. This method detects MSG at a very low concentration of 0.42 µg/mL, confirming method sensitivity. The forced degradation studies were conducted under various stress conditions. The result suggests that moderate degradation of 10.3%, 14.5%, and 9.5 % was noticed in acidic, peroxide, and reduction (9.5%) conditions. Conclusion: The purity analyses confirm the absence of significant impurities in the stress degradation chromatogram, highlighting the stability of MSG and the reliability of the proposed method. In conclusion, the proposed method was rapid, sensitive, precise, robust, and stable for quantifying MSG in pharmaceutical formulations.
Co-Authors Rao, K. V. Umamaheswara Shelke, Om Susararla, Krishna Phani Chandra