Validated HPLC Method for the Determination of Residues of Acetaminophen, Caffeine, and Codeine Phosphate on Swabs Collected from Pharmaceutical Manufacturing Equipment in Support of Cleaning Validation

2006 ◽  
Vol 29 (11) ◽  
pp. 1663-1673 ◽  
Author(s):  
Alexander H. Schmidt
Keyword(s):  
Hplc Method ◽  
Pharmaceutical Manufacturing ◽  
Codeine Phosphate ◽  
Manufacturing Equipment ◽  
Cleaning Validation

Determination of Residues of Acetaminophen, Caffeine, and Drotaverine Hydrochloride on Swabs Collected from Pharmaceutical Manufacturing Equipment Using HPLC in Support of Cleaning Validation

2014 ◽  
Vol 97 (5) ◽  
pp. 1439-1445 ◽  
Author(s):  
Mohamed E M Hassouna ◽  
Yousry M Issa ◽  
Ashraf G Zayed
Keyword(s):  
Mobile Phase ◽  
Hplc Method ◽  
Pharmaceutical Manufacturing ◽  
Manufacturing Equipment ◽  
Cleaning Validation ◽  
Accuracy And Precision ◽  
Drotaverine Hydrochloride ◽  
Time Required ◽  
Isocratic Mode

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.

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

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.

scholarly journals Determination of Fenspiride Hydrochloride Residues on Pharmaceutical Manufacturing Equipment Surfaces by HPLC Method

2018 ◽  
Vol 6 (1) ◽  
pp. 7-15
Author(s):  
Ganna Fedosenko ◽  
Alla Yegorova ◽  
Yulia Scrypynets ◽  
Inna Leonenkoa ◽  
Ekaterina Vitukova
Keyword(s):  
High Performance ◽  
Limit Of Detection ◽  
High Performance Liquid Chromatographic ◽  
Hplc Method ◽  
Pharmaceutical Manufacturing ◽  
Detection Accuracy ◽  
Manufacturing Equipment ◽  
Accuracy And Precision ◽  
Liquid Chromatographic

The cleaning procedure must be validated, so special attention must be devoted to the methods used for determination of trace amounts of drugs. A rapid, sensitive, and specific reverse phase high-performance liquid chromatographic (HPLC) method was developed for the quantitative determination of fenspiride hydrochloride residues on pharmaceutical manufacturing equipment surfaces. The calibration curve was linear over a concentration range from 1.0 to 100.0 μg/ml with a correlation coefficient of 0.99994. The detection limit and quantitation limit were 0.41 μg/ml and 1.25 μg/ml, respectively. The developed method was validated with respect to specificity, linearity, limit of detection, accuracy and precision.

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