Validation of Swab Sampling and HPLC Methods for Determination of Meloxacam Residues on Pharmaceutical Manufacturing Equipment Surfaces for Cleaning Validation
Imeda Rubashvýlý, Natela Karukhnýshvýlý, Khatuna Lorýa, Nino DvalýAversi-rational Ltd, Quality Control Laboratory,validation Department 14 chirnakhuli Str.,0198 Tbilisi, GeorgýaThe 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. 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 0.11µg/ml – 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, HPLCValidation of Swab Sampling and HPLC Methods for Determination of Meloxacam Residues on Pharmaceutical Manufacturing Equipment Surfaces for Cleaning Validation
Imeda Rubashvýlý, Natela Karukhnýshvýlý, Khatuna Lorýa, Nino DvalýAversi-rational Ltd, Quality Control Laboratory,validation Department 14 chirnakhuli Str.,0198 Tbilisi, GeorgýaThe 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. 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 0.11µg/ml – 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.
Anahtar Kelimeler: Residual estimation, Swab sampling, Cleaning validation, HPLCCorresponding Author: Imeda Rubashvýlý, Georgia
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