Cleaning Validation and Residual Analysis of Telmisartan Drug (Research Article)

Author(s): Neeraja. S, Hemalatha. S and S. Deepa

Abstract: Introduction: Cleansing validation is a foremost and complete activity which is used for industrial purposes to provide maximum protection to evolve medicinal products, such as removing particulate matter, chemicals, and adulterant microorganisms that lie in active substance of medicinal products in a part of machines that is produced or being manufactured. Cleansing validation has long been recognized as the gold standard for ensuring the effectiveness, quality, and constancy of manufacturing machines and produced goods of guaranteed standard. Materials and Methods: In order to quantify Telmisartan residues in samples from various parts of the equipment surfaces after Telmisartan 40mg tablets were manufactured, a swab sampling and HPLC method have been developed and verified. Results: The residual sample recovery was found to be less than 80 % limit. The HPLC method was prepared using mobile phase preparation, a temperature in the column of 40℃, and 298 nm detector wavelength. The detection and quantification limits were discovered to be 0.05 mcg/ml and 0.14 mcg/ml, respectively. During the analysis of residues, no contamination occurred with the swab solution or samples. Conclusion: As a result, after the production of Telmisartan 40 mg tablets, this method can be used to quantify Telmisartan residues.

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