Journal :   Asian Journal of Research in Chemistry

Volume No. :   5

Issue No. :  2

Year :  2012

Pages :   259-264

ISSN Print :  0974-4169

ISSN Online :  0974-4150


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Development and Validation of HPLC method for determination of Ketorolac tromethamine residues on the surface of manufacturing equipment



Address:   Prakash B. Modi1*, Ajay S.Vairale1, P. Sivaswaroop2
1Dr. Reddy’s Laboratories Ltd., Dermatology, Innovation Plaza, Survey No. 42, 45, 46 & 54, Bachupalli, Qutubullapur, RR Dist 500 090, Andhra Pradesh, India.
2IGNOU Regional Centre, Gyan Vatika, Amravati Road, Nagpur -440 033, Maharashtra, India.
*Corresponding Author
DOI No:

ABSTRACT:
The prevention of cross-contamination of drugs in pharmaceutical production must be avoided, therefore the cleaning of the manufacturing equipment is an important aspect of good manufacturing practice in pharmaceutical industries. A simple, sensitive and accurate HPLC method has been developed and validated for determination of Ketorolac tromethamine residues on the surface of manufacturing equipment. Separation of Ketorolac tromethamine and its impurities was achieved on Symmetry C18 (250 × 4.6 mm, 5 µ) stationary phase by using mobile phase as mixture of Water: Methanol: Glacial acetic acid (54:45:1, % v/v) at flow rate of 1.2 ml/minute. Ketorolac tromethamine was detected at 313 nm. Method was validated over the concentration range of 0.130 – 30 µg/ml. RSD of the six replicates results (Precision) was found to be 3.0%. The swabbing procedure was optimized to achieve suitable recovery of Ketorolac tromethamine from stainless steel. Recoveries were found > 85% at three different levels. The solution stability was established over period of 2 days. This method can be used to determine trace levels of Ketorolac tromethamine residues in production equipment area to confirm the efficiency of the cleaning procedure in pharmaceutical industries.
KEYWORDS:
Cleaning validation, Ketorolac tromethamine, Residue analysis, HPLC.
Cite:
Prakash B. Modi, Ajay S.Vairale, P. Sivaswaroop. Development and Validation of HPLC method for determination of Ketorolac tromethamine residues on the surface of manufacturing equipment. Asian J. Research Chem. 5(2): February 2012; Page 259-264.
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