Stability-Indicating HPTLC Method Development and Validation for analysis of Colchicine in the Bulk Drug and Tablet Dosage Forms

Registration ID: IJNRD_224076

Published ID: IJNRD2406367

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Mr Shubham Ramchandra Khade, Ms. prerna Pardeshi, Ms. Alka Bhure, Mr. Shivraj Vilas Mane

Colchicine, HPTLC, Method Validation, LODOCO

Colchicine, a potent alkaloid employed in the treatment of gout and inflammatory disorders, necessitates a robust analytical method due to its inherent instability and propensity for degradation. This study presents the development and validation of a stability-indicating High-Performance Thin-Layer Chromatography (HPTLC) method for the quantitative determination of colchicine in pharmaceutical formulations. The chromatographic conditions were optimized using silica gel plates with a mobile phase consisting of methanol, ethyl acetate, and glacial acetic acid in a 2:7:1 ratio. This method effectively separated colchicine from its degradation products, ensuring specificity under stress conditions. Colchicine spots were visualized at a wavelength of 355 nm utilizing UV detection. Validation of the method was conducted in accordance with International Conference on Harmonization (ICH) guidelines. The method exhibited excellent linearity over the concentration range, with a correlation coefficient (r) of 0.99724. Precision studies demonstrated low relative standard deviation (% RSD), with values for intra-day and inter-day variations found to be less than 2%, thereby confirming the method's repeatability and reproducibility. Accuracy was assessed through recovery studies, which yielded results within acceptable limits. In conclusion, the validated HPTLC method provides an effective solution for the quantitative determination of colchicine, ensuring pharmaceutical quality and stability assessment in drug formulations. This method's ability to accurately and reliably quantify colchicine, even in the presence of its degradation products, underscores its utility in the pharmaceutical industry, particularly in the quality control and stability testing of colchicine-containing formulations.

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Mr Shubham Ramchandra Khade, Ms. prerna Pardeshi, Ms. Alka Bhure, & Mr. Shivraj Vilas Mane (June-2024). Stability-Indicating HPTLC Method Development and Validation for analysis of Colchicine in the Bulk Drug and Tablet Dosage Forms. INTERNATIONAL JOURNAL OF NOVEL RESEARCH AND DEVELOPMENT, 9(6), d768-d775. https://ijnrd.org/papers/IJNRD2406367.pdf

Volume 9 Issue 6, June-2024

Pages : d768-d775

Paper Reg. ID: IJNRD_224076

Published Paper Id: IJNRD2406367

Downloads: 000122253

Research Area: Pharmacy

Author Type: Indian Author

Country: Pune, Maharashtra, India

Published Paper PDF: https://ijnrd.org/papers/IJNRD2406367.pdf

Published Paper URL: https://ijnrd.org/viewpaperforall?paper=IJNRD2406367

Journal Name: INTERNATIONAL JOURNAL OF NOVEL RESEARCH AND DEVELOPMENT(IJNRD)

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