. 2020; 17(2): 182-189 | |||
Cleaning method validation for estimation of dipyridamole residue on surface of the drug product manufacturing equipment using the swab sampling and by using high performance liquid chromatographic technique.Sriram Valavala1, Nareshvarma seelam1, Subbaiah Tondepu2, Vivekanandan Sundaramurthy31Department of chemistry, Koneru Lakshmaiah Education Foundation, Green Fields, Vaddeswaram, Guntur, 522502, Andhra Pradesh, India.2Department of chemical engineering, Vignan's Foundation for Science, Technology & Research, Tenali Road, Vadlamudi, Guntur, 522213, Andhra Pradesh, India. 3Research and development, Bluefish Pharmaceuticals Private Limited, Bangalore, 560115, Karnataka, India INTRODUCTION: The cleaning validation is the procedure use to ensure the cleaning process to eliminate the residues of the drug substance after drug product manufactured in the equipment surface. A simple, sensitive, robust, accurate HPLC method was developed for the quantitative estimation of dipyridamole in the swab samples from drug product manufacturing of the Dipyridamole modified release capsules equipment surface after manufacturing. Sriram Valavala, Nareshvarma seelam, Subbaiah Tondepu, Vivekanandan Sundaramurthy. Cleaning method validation for estimation of dipyridamole residue on surface of the drug product manufacturing equipment using the swab sampling and by using high performance liquid chromatographic technique.. . 2020; 17(2): 182-189 Corresponding Author: Nareshvarma seelam, India |
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