Open Access Subscription Access
Open Access Subscription Access
Spectroscopic Method for the Quantification of Residue of Tetramethylthionine Chloride on Swab from Manufacturing Equipment in Support of Cleaning Validation
Tetramethylthionine chloride is approved by the FDA for the treatment of paediatric and adult patients with acquired methaemoglobinaemia. The objective of this research was to develop and validate an Ultraviolet (UV) spectrophotometric method for quantification of Tetramethylthionine chloride in cleaning control swab sample from manufacturing equipment surfaces. Simple, accurate and cost efficient spectrophotometric method has been developed for the estimation and quantification of Tetramethylthionine chloride which is going to be used for the evaluation of cleaning in cleaning validation. The optimum conditions for the quantitative analysis of the drugs were established. The maximum wavelength (λmax) was found to be 663nm. The percent recovery of Tetramethylthionine chloride for 50.0%, 100.0% and 150.0% were 99.13, 97.76 and 101.18 respectively. Linearity of Tetramethylthionine chloride for Validation showed a good linear relationship with Correlation Coefficient (r2) value of 0.999 was obtained. Validation was performed according to the ICH guidelines of Analytical Method Validation. The Sample Solution was chemically stable up to 36 hours. The proposed may be suitable for the Estimation and Quantification of Tetramethylthionine chloride for evaluation of cleaning in cleaning validation for quality control purposes.
Tetramethylthionine Chloride, Cleaning Validation, Methylene blue, UV spectroscopy, Swab Sampling.
- World Health Organization (2019). World Health Organization model list of essential medicines: 21st list 2019. Geneva: World Health Organization. hdl:10665/325771
- British national formulary. BNF 69. British Medical Association. 2015; 69 ed. pp. 34.
- Jang, DH, Nelson, LS, Hoffman, RS. Methylene blue for distributive shock: a potential new use of an old antidote. Journal of Medical Toxicology. 2013; 9 (3): 242–9.
- National Center for Biotechnology Information (2020). PubChem Compound Summary for CID 6099, Methylene blue. Available from URL: http://www.pubchem.ncbi.nlm.nih.gov/compound/Methylene-blue.
- Hossain K, Nahar K, Mazumder EH, Gestier T, Khan TA, Hamid K. 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. Research Journal of Pharmacy and Technology 2017; 10(11): 3789-94.
- Naik S, Nazareth C, Pereira S. A Novel HPLC cleaning Validation and Assay method for the simultaneous estimation of Perindopril and Amlodipine. Research Journal of Pharmacy and Technology. 2020; 13(12): 5919-23.
- Pandharmise PN, Shahzad N, Kamble A, Bhagat MP. Cleaning Validation for Oral Solid Dosage Form and Its Importance in Pharma Industry. Research Journal of Pharmacy and Technology. 2011; 4(9): 1449-54.
- Kaur S, Bala I, Kamboj A. 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. 2017; 9(5), 141-5.
- The United States Pharmacopeia. 35-National Formulary 30. Rockville, Md: The United States Pharmacopeial Convention 2006; 29(5): p 1534.
- Pallavi P, King P, Kumar YP. Removal of Methylene Blue from an Aqueous Solution using Plumbago zeylanica Leaves-Optimisation using Response Surface Methodology (RSM). Research Journal of Pharmacy and Technology. 2018; 11(5):2006-16.
- Ravi L, Selvaraj V, Shankar S, Ranjitha Dhevi V. Sundar, Gayathri Segaran, Suganya Kumaresan, Venkatesh Sadhana. Methylene Blue Degradation by AgCuO Bimetallic Nanomaterial, Green Synthesized using Cordia sebestena leaves. Research Journal of Pharmacy and Technology. 2020; 13(7): 3122-8.
- Vijetha P, Naidu MR, Satyasree N, Reddy PR. Adsorption of Methylene Blue from aqueous solutions using Tamarindus indica. Research Journal of Pharmacy and Technology. 2017; 10(8): 2557-60.
- Sasieekhumar AR, Somanathan T, Abilarasu A, Shanmugam M. Mesoporous Fe/MCM-41 as Heterogeneous Photocatalyst for the Photodegradation of Methylene Blue. Research Journal of Pharmacy and Technology. 2017; 10(10):3398-400.
- FDA Guidance for Industry. Analytical Procedures and Method Validation, Chemistry, Manufacturing, and Controls Documentation, Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER); 2000.
- ICH, Q2 (A). Validation of analytical procedures: text and methodology. In: International Conference on Harmonization Geneva. 2005; 1-13.
- Gadiya, H, Maheshwari M, and Dashora A. UV-analytical method development and validation for simultaneous estimation of dapoxetine hydrochloride and sildenafil citrate in tablet dosage form. Asian Journal of Pharmaceutical and Clinical Research. 2019; 12(1): 328-31.
- Susmitha AS, Kokilambigai KS, Lakshmi KS. Spectrophotometric Quantification of Telmisartan Employing Multivariate Calibration Technique in Bulk and Pharmaceutical Formulations. Research Journal of Pharmacy and Technology. 2019; 12(4):1799-805.
- Prathyusha P, Sundararajan R. UV spectrophotometric method for determination of Bilastine in bulk and pharmaceutical formulation. Research Journal of Pharmacy and Technology. 2020; 13(2):933-8.
- Rele RV. UV Derivative Spectrophotometric Methods for validation of Esomeprazole Magnesium tri-hydrate in Bulk and Pharmaceutical Dosage Form. Research Journal of Pharmacy and Technology. 2018; 11(1): 135-8.
- Raul SK, Spandana B, Sameera P, Vikitha V. UV Spectrophotometric Method Development and Validation for the Estimation of Gliclazide in Bulk and Pharmaceutical Dosage Form. Asian Journal of Pharmaceutical Analysis. 2016; 6(3): 143-146.
- Matole V, Birajdar A, Ingle S, Adlinge S, Nangare G, Madur S et al.. UV Spectrophotometric Method Development and Validation of Acotiamide in Bulk and Solid Doage Form. Asian Journal of Pharmaceutical Analysis. 2020; 10(3): 147-149.
Abstract Views: 11
PDF Views: 0