Development of a Cleaning Validation Protocol for an Odd Case Scenario and Determination of Methoprene residues in a Pharmaceutical Manufacturing Equipment Surfaces by using a Validated UFLC Method

Abstract An HPLC method was developed for the simultaneous determination of residues of acetaminophen (paracetamol, PA), caffeine (CA), and drotaverine HCl (DH) on swabs collected from pharmaceutical manufacturing equipment surfaces. The challenge in cleaning validation is to develop analytical methods that are sensitive enough to detect traces of the active compounds remaining on the surface of pharmaceutical manufacturing equipment after cleaning. Chromatography was performed in the isocratic mode on a Hypersil C18 BDS column using the mobile phase 0.02 M tetrabutylammonium bisulfate–methanol (100 + 45, v/v) at 50°C with UV detection at 210 nm. The method was tested for specificity, linearity, LOD, LOQ, accuracy, and precision for determination of traces of the above-mentioned drugs. The time required for a single analysis was 12 min. The response was linear in the ranges of 6.900–52.100, 1.040–7.800, and 0.694–5.210 μg/mL for PA, CA, and DH, respectively.

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

Turkish Journal of Pharmaceutical Sciences ◽

10.5505/tjps.2015.43531 ◽

2015 ◽

Vol 12 (3) ◽

pp. 40-52 ◽

Cited By ~ 1

Author(s):

Imeda Rubashvılı ◽

Natela Karukhnıshvılı ◽

Khatuna Lorıa ◽

Nino Dvalı

Keyword(s):

Pharmaceutical Manufacturing ◽

Manufacturing Equipment ◽

Cleaning Validation

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DEVELOPMENT AND VALIDATION OF ANALYTICAL METHOD FOR ESTIMATION OF ARIPIPRAZOLE IN SWAB SAMPLES ON PHARMACEUTICAL MANUFACTURING EQUIPMENT SURFACES FOR CLEANING VALIDATION

International Journal of Pharmacy and Pharmaceutical Sciences ◽

10.22159/ijpps.2017v9i5.13788 ◽

2017 ◽

Vol 9 (5) ◽

pp. 141

Author(s):

Sukhpreet Kaur ◽

Indu Bala ◽

Anjoo Kamboj

Keyword(s):

Analytical Method ◽

Sampling Method ◽

Pharmaceutical Manufacturing ◽

Manufacturing Equipment ◽

Cleaning Procedure ◽

Cleaning Validation ◽

Production Area ◽

Development And Validation ◽

Validation Of Analytical Method

Objective: To validate simple analytical method and its application in the determination of residual aripiprazole in production area equipment and to confirm the efficiency of cleaning procedure.Methods: The swab sampling and UV method for residual estimation of aripiprazole in swab samples from equipment surfaces after manufacturing of three consecutive batches of aripiprazole 10 mg uncoated tablets were developed and validated.Results: The swab sampling method was developed and validated in order to obtain the suitable recovery (>90%). The swabs were saturated with acetonitrile. The UV method was developed using UV-Vis spectrophotometer at 255 nm. The calibration curve was linear (r2 =1.0000) over a concentration range of 1-30 µg/ml. The LOD and LOQ were 0.43 µg/ml and 1.32µg/ml, respectively. No interference from swab solution was observed and samples were stable for 24h. The determined concentration varying from 1.00-5.687µg/swab was well below the calculated limit of contamination i.e., 24.2µg/swab or 24.2 µg/25 cm2.Conclusion: The results obtained from cleaning procedure confirmed that the proposed procedure was able to remove aripiprazole from equipment surfaces below the value of 10 ppm criteria. So the proposed validated UV method with appropriate swab wipe procedure could be applicable for cleaning validation on residues of aripiprazole.

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