A VALIDATED HPLC METHOD FOR DETERMINATION OF METFORMIN HYDROCHLORIDE ON THE SURFACE OF MANUFACTURING EQUIPMENT

Cleaning validation plays an important role in redu cing the possibility of product contamination from pharmaceutical manufacturing equipment. It demonstrates that the cleaning process adequately and consistently remove s product residues, process residues and environmental contaminates from the manufacturing equipment. An accurate, simple and sensitive HPLC method has been developed and validated for estimation of Metformin hydrochloride residues on the surface of manufactur ing equipment. Nucleodur 100-5 C18 (250 ◊ 4.6 mm, 5 µ) stationary phase by using mobile phase pH 3.5 of 0.025M Phosphate buffer and 0.004 M Octane sulphonic acid sodium salt monohydrate: Acetonitrile: Methanol (70: 20:10), % v/v/v) at flow rate of 1.2 ml/minute. Metformin hydrochloride is having an absorption maximum at 233 nm. Method was linear in the concentration range of 0.025‐2.505 µg/ml. RSD of the six replicates results (Precision) was found to be 0.8%. The swabbing procedure was optimized to achieve suitable recovery of Metformin hydrochloride from stainless steel surfaces. Recove ry of the method was found to be > 85%. This method can be used to estimate trace leve ls of Metformin hydrochloride residues in production equipment area to confirm the efficie ncy of the cleaning procedure in pharmaceutical industries to avoid cross contaminat ion.