Keywords:-

Keywords: cleaning validation; swab sampling; method validation.

Article Content:-

Abstract

Pharmaceutical products may be contaminated by various substances such as microbiological contaminants, previous products (residues of active pharmaceutical ingredients and excipients), the residuals of cleaning products and residue generated during the cleaning process, using strong acids and bases, and degradation of detergents, acids and bases that can be used as part of the cleaning process. Requirements of Good Manufacturing Practice include prevention of possible contamination and cross-contamination arising from pharmaceutical starting materials, products, cleaning equipment. Appropriate purification techniques play an important role in the prevention of contamination and cross-contamination. Effective cleaning ensure reduction in the risk of contamination to the lowest acceptable level. Validation confirms the efficiency of the cleaning process, which is necessary to achieve adequate cleanliness of equipment to prevent product contamination. The aim of this work is to present ultra performance liquid chromatography method (UPLC) for determining residues of glibenclamide on production equipment. The optimum results were obtained were: column C-18; 2.1 mm x 50 mm; 1.7 μm, kept at 35°C. The mobile phase was 45% V/V acetoniril, contains 1 ml of phosphoric acid. Flow rate was 0.2 ml/min. UV detection was performed at 230 nm. The method has been validated accordance Guidelines ICH Q2 (R1).

References:-

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Džambić, L. A., Kulenović, M. P.-, & Ćeranić, M. (2016). Uplc method for determination of glibenclamide residual on manufacturing equipment. RA Journal Of Applied Research, 2(10), 685-688. Retrieved from http://rajournals.in/index.php/rajar/article/view/398