Cleaning Method Validation for Estimation of Dipyridamole Residue on the Surface of Drug Product Manufacturing Equipment Using Swab Sampling and by High Performance Liquid Chromatographic Technique
Journal Title: Turkish Journal of Pharmaceutical Sciences - Year 2020, Vol 17, Issue 2
Abstract
Objectives: Cleaning validation is the procedure used to ensure that the cleaning process has eliminated the residues of drug substance from on the equipment surface after manufacture. A simple, sensitive, robust, and accurate high performance liquid chromatographic method was developed for the quantitative estimation of dipyridamole in swab samples obtained from the equipment surface after the manufacture of dipyridamole modified release capsules. Materials and Methods: The method was developed by using a Hypersil BDS C18 (150×4.6 mm, 5 μm) column with mobile phase containing a mixture of buffer (potassium dihydrogen phosphate buffer, pH 7.0±0.05) and methanol in the ratio of 30:70 v/v. Flow rate was 1.5 mL/min, column temperature was 45°C, and injection volume was 5 μL. Results: The method was validated and a specificity study was conducted to prove that there was no interference from blank and swab blank at the retention time of dipyridamole. The limit of detection and limit of quantification (LOQ) were established by using a series of linearity solutions and were found to be 0.041 μg/mL and 0.124 μg/mL, respectively. The method precision at the LOQ level was 8.6% relative standard deviation (RSD), method precision was 0.2% RSD, and ruggedness was 0.3% RSD. The method was accurate from the concentration of 0.13 μg/mL to 21.80 μg/mL and the recovery results met the acceptance criteria. The linearity of the method was found from 0.12 μg/mL to 20.14 μg/mL and the r2 value was 0.997. The robustness for the flow rate, wavelength, column temperature, buffer pH, and mobile phase ratio variations was tested, and all the system suitability parameters were met. Conclusion: The method validation was performed as per the regulatory requirements and guidelines. The validation parameters met the acceptance criteria and the proposed method can be applied for the intended routine swab analysis.
Authors and Affiliations
Sriram VALAVALA, Nareshvarma SEELAM, Subbaiah TONDEPU, Vivekanandan SUNDARAMURTHY
Keywords
Related Articles
- EP ID EP684747
- DOI 10.4274/tjps.galenos.2019.70446
- Views 156
- Downloads 0
Nanocarriers Used Most in Drug Delivery and Drug Release: Nanohydrogel, Chitosan, Graphene, and Solid Lipid
Over the past few years, nanocarriers have become an ideal solution for safe and efficient drug delivery and release. This is mainly due to the extraordinary characteristics that nanomaterials exhibit when compared with...
Deposition Pattern of Polydisperse Dry Powders in Andersen Cascade Impactor - Aerodynamic Assessment for Inhalation Experimentally and In Silico
Objectives: An impactor is a standard instrument that applied for particle deposition assessment in the pharmaceutical aerosols. It provides data comparison between inhaler formulations. However, the deposition pattern i...
Comparative Proteomic Analysis of Escherichia coli Under Ofloxacin Stress
Objectives: In the present study, proteomics was utilized to evaluate changes in Escherichia coli proteins in response to ofloxacin to understand the mechanism of action of ofloxacin and the mechanisms of ofloxacin resis...
Investigation of the Compressibility Characteristics of Paracetamol using “Compaction Simulator”
Objectives: This study was performed to understand the behavior of poorly compressible paracetamol powder using a compaction simulator (CS), equipment that records data during the compaction process. The aim was to inves...
Antifungal and Antibiofilm Activities of Selective Serotonin Reuptake Inhibitors Alone and in Combination with Fluconazole
Objectives: Candida spp. are clinically important pathogens that cause difficulties for treatment by biofilm formation. Considering antifungal resistance rates and the limitations in the discovery of new antifungals, the...