Original Article

Validation of Swab Sampling and HPLC Methods for Determination of Meloxicam Residues on Pharmaceutical Manufacturing Equipment Surfaces for Cleaning Validation

  • Khatuna LORIA
  • Nino DVALI

Received Date: 02.04.2015 Accepted Date: 18.06.2015 Turk J Pharm Sci 2015;12(3):287-298

The swab sampling and HPLC methods for residual estimation of meloxicam in swab samples from equipment surfaces after manufacturing of Mobicam 15 mg (meloxicam 15 mg) uncoated tablets were developed and validated. The swab sampling method was developed and optimized in order to obtain a suitable recovery (>90 %). Polyester swabs were moistened with diluent - a mixture of methanol, 1 M sodium hydroxide solution and water 28:2:20, v/v/v. The HPLC method was developed using Luna C18(2) 150 × 4.6 mm, 5 μm column with a mobile phase - a mixture of solution A and solution B (63 : 37); the flow rate – 0.8 mL/min; the column temperature - 40°C; the detector wavelength - 254 nm; the injection volume – 25 μL. The calibration curve is linear (the r2=1.00000) over a concentration range 0.11–88 μg/mL; the limit of detection and the limit of quantitation are 0.11μg/mL and 0.014 μg/mL, respectively; no interference from swab solution was observed and samples were stable for 24 h. The determined concentration varying 0.016 – 5.8 μg/mL are well below the calculated limit of contamination. So the proposed validated HPLC method with appropriate swab wipe procedure could be applicable for cleaning validation on residues of meloxicam.

Keywords: Residual estimation, Swab sampling, Cleaning validation, HPLC