%0 Journal Article
%T A validated RP-HPLC method for the determination of Irinotecan hydrochloride residues for cleaning validation in production area M¨¦todo RP- HPLC validado para la determinaci¨®n de residuos de Irinotecan Hidrocloruro para la validaci¨®n de la limpieza en el ¨¢rea de producci¨®n
%A Sunil Reddy
%A K Sudhakar Babu
%A Navneet Kumar
%J Revista Cubana de Farmacia
%D 2013
%I ECIMED
%X Introduction: cleaning validation is an integral part of current good manufacturing practices in pharmaceutical industry. The main purpose of cleaning validation is to prove the effectiveness and consistency of cleaning in a given pharmaceutical production equipment to prevent cross contamination and adulteration of drug product with other active ingredient. Objective: a rapid, sensitive and specific reverse phase HPLC method was developed and validated for the quantitative determination of irinotecan hydrochloride in cleaning validation swab samples. Method: the method was validated using waters symmetry shield RP-18 (250mm x 4.6mm) 5 ¦Ìm column with isocratic mobile phase containing a mixture of 0.02 M potassium di-hydrogen ortho-phosphate, pH adjusted to 3.5 with ortho-phosphoric acid, methanol and acetonitrile (60:20:20 v/v/v). The flow rate of mobile phase was 1.0 mL/min with column temperature of 25¡ãC and detection wavelength at 220nm. The sample injection volume was 100 ¦Ìl. Results: the calibration curve was linear over a concentration range from 0.024 to 0.143 ¦Ìg/mL with a correlation coefficient of 0.997. The intra-day and inter-day precision expressed as relative standard deviation were below 3.2%. The recoveries obtained from stainless steel, PCGI, epoxy, glass and decron cloth surfaces were more than 85% and there was no interference from the cotton swab. The detection limit (DL) and quantitation limit (QL) were 0.008 and 0.023 ¦Ìg ml-1, respectively. Conclusion: the developed method was validated with respect to specificity, linearity, limit of detection and quantification, accuracy, precision and solution stability. The overall procedure can be used as part of a cleaning validation program in pharmaceutical manufacture of irinotecan hydrochloride.
%K Cleaning validation
%K Irinotecan
%K HPLC-UV
%K Residues
%K Swab analysis
%U http://scielo.sld.cu/scielo.php?script=sci_arttext&pid=S0034-75152013000100005