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Original Articles Open Access
In Pharmaceutical industry, the important step in the cleaning of equipment involves the removal of possible drug residues from the equipment surface and surrounding areas. The cleaning procedure must be validated and the methods to determine trace amounts of drugs have, therefore, to be considered with special attention. A simple, selective, rapid, precise and economical reverse phase high performance liquid chromatographic method has been developed for the simultaneous estimation of paracetamol and diclofenac potassium on stainless steel equipments in order to control cleaning procedure. Cotton swab, moistened with water: methanol(50:50) is used to remove any residue from surface. The drug analysis was carried out on a Hibar C18 (25 cm x 4.6 mm i.d., 5 μ) column with a mobile phase consisting of acetonitrile: potassium dihydrogenortho phosphate (adjusted to pH 3 using orthophosphoric acid) in the ratio of 70:30 v/v at a flow rate of 0.8 ml/min. Detection was carried out at 275 nm. The retention times of paracetamol and diclofenac potassium were 3.1 and 7.4 min, respectively. The developed method was validated in terms of accuracy, precision, linearity, limit of detection, limit of quantitation and solution stability. The developed method was also successfully applied to evaluate the residue and drugs on the surface of the stainless steel equipments used for manufacturing solid tablet dosage form.
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Author(s): Sindhur Nag N Gouthami B Madhuri L Krishnaveni N Meyyanathan S N and Suresh B
RP-HPLC, Paracetamol, Diclofenac potassium, Cleaning Validation., Development and validation