International Journal on Science and Technology

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Validated Rp-Hplc Method For The Sensitive Determination Of Potent Hormonal Drug Residues In Support Of Cleaning Validation In Pharmaceutical Manufacturing Equipment Surfaces

Author(s) Sudeep Bhatt
Country India
Abstract The detection and quantification of potent hormonal drug residues on pharmaceutical manufacturing equipment surfaces are paramount for ensuring product safety and efficacy, particularly during cleaning validation. This paper presents the development and validation of a reversed-phase high-performance liquid chromatography (RP-HPLC) method for the sensitive determination of hormonal drug residues in pharmaceutical manufacturing environments. The validated method demonstrates high specificity, accuracy, and sensitivity for detecting residues even at trace levels, which is essential for maintaining cleaning standards and preventing cross-contamination between drug products. The study explores the challenges of residual analysis, method optimization, and regulatory requirements in the pharmaceutical industry, underscoring the importance of robust analytical tools in maintaining pharmaceutical production quality.
Keywords • Hormonal • highly potent • Sensitive Determination • Liquid Chromatography • Validation • Pharmaceuticals • Cleaning.
Field Chemistry
Published In Volume 16, Issue 1, January-March 2025
Published On 2025-01-11
Cite This Validated Rp-Hplc Method For The Sensitive Determination Of Potent Hormonal Drug Residues In Support Of Cleaning Validation In Pharmaceutical Manufacturing Equipment Surfaces - Sudeep Bhatt - IJSAT Volume 16, Issue 1, January-March 2025. DOI 10.71097/IJSAT.v16.i1.1381
DOI https://doi.org/10.71097/IJSAT.v16.i1.1381
Short DOI https://doi.org/g82pcd
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