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Method Development, Validation, control of in salbutamol solutions, control of electrical conductivity in salbutamol solutions
Analytical method development and validation play an important role in the discovery, development, and manufacturing of pharmaceuticals. The process validation is of utmost importance while manufacturing a quality product. Salbutamol sulfate (SBS) is a very potent bronchodilator and is used extensively for treating different respiratory problems such as bronchial congestion, asthma and Chronic Obstructive Pulmonary Disease (COPD), etc. In this study, a method of need was developed for prospects to be used for better advances in solution stability and preservation by controlling pH and electrical conductivity. This method was developed using a pH/conductivity meter of accuracy ±0.02 and all procedures were done by maintaining the temperature of the solution at 25°C. The de-ionized water was used as a solvent to minimize any contaminant ions activity. During method development, the development, measurement and validation of the pH and electrical conductivity were performed. For developing a method for control the pH value of the solution was maintained at 5.00 so that the results show that the method developed is precise and accurate. Different validation parameters were studied such as linearity, accuracy, precision and robustness. The method was validated according to standard guidelines. The routine calibration of the pH/conductivity meter was done to obtain accurate readings and to avoid any mishandling of any step throughout the process. The results were precise and showed that the method developed is accurate. The method developed is suitable for the control of pH and electrical conductivity for the different solutions as these characteristics are necessary for their stability, quality and efficacy. The method developed is precise, stable and also enhances the action of salbutamol sulfate. It can serve as a new window for researchers to analyze and control the pH and conductivity of different formulations.
2. Food U, Administration D. Analytical Procedures and Methods Validation for Drugs and Biologics Guidance for Industry. Silver Spring, MD: US Food and Drug Administration, US Department of Health and Human Services. 2015.
3. Chapters UPG, editor 791 pH. USP32-NF27 Rockville, MD: US Pharmacopeial Convention; 2011.
4. Liu Q, Li Q, Han T, Hu T, Zhang X, Hu J, et al. Study of pH stability of R-salbutamol sulfate aerosol solution and its antiasthmatic effects in guinea pigs. Biological and Pharmaceutical Bulletin. 2017;40(9):1374-80.
5. Kanter M, Coskun O, Uysal H. The antioxidative and antihistaminic effect of Nigella sativa and its major constituent, thymoquinone on ethanol-induced gastric mucosal damage. Archives of toxicology. 2006;80:217-24.
6. Cohen E, Cvitas T, Frey J. IUPAC quantities, units and symbols in physical chemistry. IUPAC and RSC Publishing, Cambridge. 2007.
7. Elizabeth Prichard RL. Measurement of PH.
8. Bell RP. Acid–base reaction 2018. Available from: https://www.britannica.com/science/acid-base-reaction.
9. Kolb D. Acids and Bases. Journal of Chemical Education. 1978;55(7):459.
10. Kauffman GB. The Bronsted-Lowry acid base concept. Journal of Chemical Education. 1988;65(1):28.
11. F. M. HALL MS. THE THEORY OF ACIDS AND BASES.
12. Brady NC, Weil RR. The nature and properties of soils. 14th ed. ed: Upper Saddle River; 2008.
13. Usp. Conductivity of Solutions: The United States Pharmacopeial Convention; 2019 1st august
14. LeBlanc M. Wasserstoffelektrode. Z physik Chem. 1893;12:133.
15. Hills G, Jacobs P, Lakshminarayanaiah N. Membrane Potentials I. The Theory of the emf of cells containing ion-exchange membranes. Proceedings of the Royal Society of London Series A Mathematical and Physical Sciences. 1961;262(1309):246-56.
16. Rabinovich D. A Century of pH Measurements. Chemistry International. 2010;32(2):3.
17. Haider C, Metrohm A. Electrodes in potentiometry.
18. Koryta JJAroms. Ion-selective electrodes. 1986;16(1):13-27.
19. Boyes W. Instrumentation reference book: Butterworth-Heinemann; 2009.
20. Lawn R, Prichard E. Measurement of PH: Royal Society of Chemistry; 2003.
21. Cheng K, Zhu D-MJS. On calibration of pH meters. 2005;5(4):209-19.
22. Hines WG, de Levie RJJoCe. The early development of electronic pH meters. 2010;87(11):1143-53.
23. Mesmer R, Holmes H. pH, definition and measurement at high temperatures. Journal of solution chemistry. 1992;21(8):725-44.
24. Conover W. Buffer Solutions: The Basics (Beynon, RJ; Easterby, JS). ACS Publications; 1998.
25. Perrin D. Buffers for pH and Metal Ion Control: Springer Netherlands; 2012.
26. Van Slyke DD. On the measurement of buffer values and on the relationship of buffer value to the dissociation constant of the buffer and the concentration and reaction of the buffer solution. Journal of Biological Chemistry. 1922;52(2):525-70.
27. 35-NF U. Solutions/Buffer solutions the Uniited States Pharmacopeil Convention; 2012 december 1. 5773 p.
28. Depot TL. PH MEASUREMENT.
29. HORIBA L. Measurement of pH in Many Fields. 1996-2020.
30. Sadeghi M, Babaeian E, Arthur E, Jones SB, Tuller M. Soil Physical Properties and Processes. Handbook of Environmental Engineering. 2018:137-207.
31. Anne Marie Helmenstine PD. Electrical Conductivity DefinitionElectrical Conductivity Definition 2018. Available from: https://www.thoughtco.com/definition-of-electrical-conductivity-605064.
32. HORIBA L. Theory and practical measurement of conductivity. 1996-2020.
33. Managemenat EP. Theory and Application of Conductivity.(2010). Application Data Sheet ADS 43-018/rev. D January 2010. 2014.
34. Analytical R. 2003.
35. Helmenstine AM, Ph.D. definition of electrical conductivity. thoughtcocom2018.
36. Connelly A. 2017. Available from: https://andyjconnelly.wordpress.com/2017/07/14/conductivity-of-a-solution/.
37. Shreiner R, Pratt K. Standard reference materials: primary standards and standard reference materials for electrolytic conductivity. NIST Special Publication. 2004;260:142.
38. Barron JJ, Ashton C. The effect of temperature on conductivity measurement.
39. Gray JR. Conductivity analyzers and their application. Environmental instrumentation and analysis handbook. 2004:491-510.
40. Ganjali MR, Shirvani‐Arani S, Nourozi P, Salimzadeh D, Faal‐Rastegar M, Moghimi AJEAIJDtF, et al. A Novel Sulfate Polymeric Membrane Sensor Based on a New Bis‐Pyrylium Derivative. 2004;16(12):1009-13.
41. Attaran AM, Javanbakht M, Fathollahi F, Enhessari MJE. Determination of salbutamol in pharmaceutical and serum samples by adsorptive stripping voltammetry on a carbon paste electrode modified by iron titanate nanopowders. 2012;24(10):2013-20.
42. Swartz ME, Krull IS. Analytical method development and validation: CRC Press; 2018.
43. Sowjanya G, Sankar D, Rao J. DEVELOPMENT AND VALIDATION OF A NEW RP-HPLC METHOD FOR THE SIMULTANEOUS DETERMINATION OF ALBUTEROL SULPHATE AND IPRATROPIUM BROMIDE IN NASAL INHALATIONS. International Research Journal Of Pharmacy. 2018;9:63-70.
44. Muralidharan S, Kumar J. High performance liquid chromatographic method development and its validation for salbutamol. Journal of Pharmaceutical Research International. 2012:228-37.
45. Guideline IHT, editor Validation of analytical procedures: text and methodology Q2 (R1). International conference on harmonization, Geneva, Switzerland; 2005.
46. Stromer T. Die Schweiz: praktisches handbuch für reisende: A. Goldschmidt; 1895.
47. Lindino CA, Bulhões LOSJT. Determination of fenoterol and salbutamol in pharmaceutical formulations by electrogenerated chemiluminescence. 2007;72(5):1746-51.
48. Ganjali MR, Norouzi P, Ghorbani M, Sepehri AJT. Fourier transform cyclic voltammetric technique for monitoring ultratrace amounts of salbutamol at gold ultra microelectrode in flowing solutions. 2005;66(5):1225-33.
49. Njaria PM, Abuga KO, Kamau FN, Chepkwony HK. A versatile HPLC method for the simultaneous determination of bromhexine, guaifenesin, ambroxol, salbutamol/terbutaline, pseudoephedrine, triprolidine, and chlorpheniramine maleate in cough–cold syrups. Chromatographia. 2016;79(21-22):1507-14.
50. Pharmacopeia US, editor USP 37–NF32. General chapter on validation of compendial procedures< 1225>2014: United States Pharmacopeial Convention Rockville, MD.
51. Shabir GA. Step-by-step analytical methods validation and protocol in the quality system compliance industry. Journal of validation technology. 2005;10:314-25.
52. Lai P. Validating instruments of measure: Is it really necessary? Malaysian family physician: the official journal of the Academy of Family Physicians of Malaysia. 2013;8(1):2.
53. Vuolo-Schuessler L, Newton ME, Smith P, Burgess C, McDowall R. Harmonizing USP< 1058> and GAMP for analytical instrument qualification. Pharmaceutical Engineering. 2014;34(1):1-8.
54. Smith P. Trends in analytical instrument qualification. BioProcess International. 2007(10):30-8.
55. Blessy M, Patel RD, Prajapati PN, Agrawal Y. Development of forced degradation and stability indicating studies of drugs—A review. Journal of pharmaceutical analysis. 2014;4(3):159-65.
56. Dodson LG, Vogt RA, Marks J, Reichardt C, Crespo-Hernández CEJC. Photophysical and photochemical properties of the pharmaceutical compound salbutamol in aqueous solutions. 2011;83(11):1513-23.
57. Zhou L, Wang Q, Zhang Y, Ji Y, Yang X. Aquatic photolysis of β2-agonist salbutamol: kinetics and mechanism studies. Environmental Science and Pollution Research. 2017;24(6):5544-53.
58. Cazzola M, Page CP, Rogliani P, Matera MGJAjor, medicine cc. β2-agonist therapy in lung disease. 2013;187(7):690-6.
59. Cullum VA, Farmer J, Jack D, Levy GJBjop. Salbutamol: a new, selective β‐adrenoceptive receptor stimulant. 1969;35(1):141-51.
60. Pharmacopoeia B. Salbutamol. 2018 ed2018 1st jan, 2018.
61. Chen K, Schmidt CFJJoP, Therapeutics E. The action of ephedrine, the active principle of the Chinese drug Ma Huang. 1924;24(5):339-57.
62. Ahrens RC, Smith GDJPTJoHP, Therapy D. Albuterol: an adrenergic agent for use in the treatment of asthma pharmacology, pharmacokinetics and clinical use. 1984;4(3):105-20.
63. Walker S, Evans M, Richards A, Paterson JWJCP, Therapeutics. The clinical pharmacology of oral and inhaled salbutamol. 1972;13(6):861-7.
64. Price AH, Clissold SP. Salbutamol in the 1980s. Drugs. 1989;38(1):77-122.
65. M. El Ouchy KEO, M. Machkou, A. El Oualti, F. Ouazzani Chahd,, Lalami. FZaAEO. Analytical validation of method for control of pH and electrical conductivity. Journal of Chemical and Pharmaceutical Research. 2016.
66. Chen C, Li H, Fan Y. [Determination of salbutamol sulfate in medicaments by capillary electrophoresis with contactless conductivity detection]. Se pu = Chinese journal of chromatography. 2011;29(2):137-40.
67. Amare M, Menkir GJH. Differential pulse voltammetric determination of salbutamol sulfate in syrup pharmaceutical formulation using poly (4-amino-3-hydroxynaphthalene sulfonic acid) modified glassy carbon electrode. 2017;3(10):e00417.
68. Issa YM, Shoukry AF, El-Nashar RM. Conductimetric determination of reproterol HCl and pipazethate HCl and salbutamol sulphate in their pharmaceutical formulations. Journal of Pharmaceutical and Biomedical Analysis. 2001;26(3):379-86.
69. AL-Rufaie MMM, Yosif Z. Preparation and Description of Potentiometric Electrode for the limitation of Sulbutamol Sulphate.
70. Robison G, Butcher R, Sutherland E. Cyclic AMP, New York, 1971. Academic Press, Inc.
71. Ahmed AAE-MM. Development and validation of advanced analytical techniques for the determination of some drugs in pharmaceutical mixtures or in the presence of their degradation products. CU Theses. 2018.
72. Klosterhaus SL, Grace R, Hamilton MC, Yee D. Method validation and reconnaissance of pharmaceuticals, personal care products, and alkylphenols in surface waters, sediments, and mussels in an urban estuary. Environment international. 2013;54:92-9.