• Corpus ID: 54712580

CLEANING VALIDATION METHOD FOR RESIDUAL ESTIMATION OF AMC AND RUTIN ON SURFACE OF PHARMACEUTICAL MANUFACTURING EQUIPMENT WITH SWAB SAMPLING TECHNIQUE BY USING HPLC UV METHOD

@inproceedings{Lakka2014CLEANINGVM,
  title={CLEANING VALIDATION METHOD FOR RESIDUAL ESTIMATION OF AMC AND RUTIN ON SURFACE OF PHARMACEUTICAL MANUFACTURING EQUIPMENT WITH SWAB SAMPLING TECHNIQUE BY USING HPLC UV METHOD},
  author={N. S. Lakka and Sapthagiri Y. Reddamoni and Vure Prasad and K. Sivakumarb},
  year={2014}
}

• N. S. Lakka, S. Y. Reddamoni, +1 author K. Sivakumarb
• Published 2014
• Materials Science

Introduction: Cleaning validation helps in the pharmaceutical field to avoid potential clinically significant synergistic interactions between pharmacologically active chemicals. Cleaning validation involves using an analytical instrument to perform quantitative analysis of residues in manufacturing equipment. Objective: The objective of this research is to develop and validate a single reverse phase-high performance liquid chromatography (RP-HPLC) method for determination of AMC-Rutin in Vitamin K tablets. Methods: AMC-Rutin estimated using Phenomenex Synergi 4µ Polar-RP 80A column at 1.2 mL/min flow rate at 354 nm. The mobile phase consists of a mixture of acetonitrile: methanol: pH 4.0 buffer (15:10:75, v/v/v). Results: Recoveries were found to be in the range of 89.0% to 100.1% with R.S.D below 2.0% at three concentration levels. Residual concentration was found to be linear in the range of 0.0075 to 0.1652 µg/mL for AMC and 0.0829 to 1.2435 µg/mL for Rutin. The LOD and LOQ for AMC and Rutin were found to be 0.00250 & 0.02763, and 0.0075 & 0.0829 µg/mL, respectively. Conclusion: A simple, precise and accurate method was developed and subsequently validated for simultaneous estimation of AMC-RUT residues on surface of manufacturing equipment by RP-HPLC. The validated method was found to be simple, selective and sensitive for demonstration of cleaning validation of AMC and Rutin residues on the stainless steel surface and manufacturing equipment. This method can be used to determine trace levels of AMC-RUT residues in production equipment area to confirm efficiency of cleaning procedure in pharmaceutical industries to avoid cross contamination.