Determination of the glucose residues on pharmaceutical equipment surfaces by both methods: polarimetry and HPLC

Abstract

Cleaning of equipment in the production of medicines is an important requirement of good manufacturing practice (GMP). As a rule, the same process equipment is used for the production of a number of different drugs that may result in cross-contamination. In order to prevent the contamination there is need in efficient cleaning of equipment used with the validation methods for each part of equipment. There is need as well to prove and establish acceptable residual limits of active pharmaceutical ingredients (API) on the surface of the equipment after purification (purity acceptance criteria) based on the therapeutic dose of API, toxicity, volume of series, the surface area of the used equipment.
 The aim of this work is the development of the simple and selective polarimetry and HPLC methods for determining residual amounts of glucose in washings from surfaces of pharmaceutical equipment after production of the drug. The object of the research is glucose, which is a part of the drug Regidron, powder for oral solution of 18.9 g per sachet. The swab Alpha® Sampling Swab TX715; membrane filters 0.20 µm; Minisart RC 15 «Sartorius» (Germany) were used. The polarimetric and HPLC methods for determination of glucose residues in washings from surfaces of pharmaceutical equipment after production the Regidron were developed.
 The recovery rates of glucose from swabs and pharmaceutical equipment surfaces are more than 90%. The proposed simple and rapid methods are characterized by satisfactory metrological characteristics and can be recommended to determine the residues of glucose in controlling the quality of cleaning pharmaceutical equipment.