Fast and Accurate Quantitative Determination of Prednisolone and Chlorpheniramine in Active Pharmaceutical Ingredients and Parenteral Dosage Forms doi.org/10.26538/tjnpr/v5i11.5
Main Article Content
Abstract
The approaches for quantitative drug analysis utilizing HPLC is hectic and time-consuming. The
present research was conducted to develop an efficient and facile method for the simultaneous
quantitative analysis of chlorpheniramine (CPM) and prednisolone (Pred) with reasonable
accuracy and precision both in active pharmaceutical ingredient (API) and its parenteral dosage
forms. C18 (5µm x 150 mm 4.6 mm) HPLC column with 50:50 v/v acetonitrile: buffer (0.008M
sodium dihydrogen phosphate [NaH2PO4]) as mobile phase was used. The run time for the
analysis was 10 min, while the retention times of CPM and Pred were 1 and 4 min, respectively.
The developed method showed linearity, intermediate precision, and accuracy within the defined
set limits according to international standards. Verification of this method was done on the
parenteral dosage forms of both drugs. Linearity with R2 values of 0.991607 for CPM and
0.990061 for Pred was obtained. Limit of detection and limit of quantification for Pred were
calculated to be 0.033 and 0.11 mg/mL, while for CPM, 0.08 and 0.27 mg/mL were obtained.
Accuracy parameter outcomes for Pred were within the range of 98.16576 to 98.46571% and the
values for CPM were 98.10 to 99.57%. The validation results of the developed method are
accurate and within system suitability parameters provided by International Council for
Harmonization ICH and pharmacopeias.
Keywords: , , .
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References
Yamauchi K and Ogasawara M. The role of histamine in the pathophysiology of asthma and the clinical efficacy of antihistamines in asthma therapy. Int J Mol Sci. 2019;
(7):1733.
Mandola A, Nozawa A, Eiwegger T. Histamine, histamine receptors, and anti-histamines in the context of allergic responses. Lymph J. 2019; 6(2):35-51.
Durante M, Sgambellone S, Lanzi C, Nardini P, Pini A, Moroni F, Masini E, Lucarini L. Effects of PARP-1 deficiency and histamine H4 receptor inhibition in an inflammatory model of lung fibrosis in mice. Front Pharm. 2019; 10:525.
Bolam JP and Ellender TJ. Histamine and the striatum. Neuropharm. 2016; 106:74-84.
Sadek B, Saad A, Sadeq A, Jalal F, Stark H. Histamine H3 receptor as a potential target for cognitive symptoms in neuropsychiatric diseases. Behav Brain Res. 2016; 312:415-
Arrang JM, Garbarg M, Schwartz JC. Auto-inhibition of brain histamine release mediated by a novel class (H3) of histamine receptor. J Nat. 1983; 302(5911):832.
Cox JH, Seri S, Cavanna AE. Safety and efficacy of aripiprazole for the treatment of pediatric Tourette syndrome and other chronic tic disorders. Pedia Helth Med Ther. 2016; 7:57-64.
Takeshita K, Bacon KB, Gantner F. Critical role of Lselectin and histamine H4 receptor in zymosan-induced neutrophil recruitment from the bone marrow: Comparison with carrageenan. J Pharm Exper Ther. 2004; 310(1):272-280.
Salem A, Rozov S, Al‐Samadi A, Stegajev V, Listyarifah D, Kouri VP. Histamine metabolism and transport are deranged in human keratinocytes in oral lichen planus. Br J Derm. 2017; 176(5):1213-1223.
Dunford PJ, Williams KN, Desai PJ, Karlsson L, McQueen D, Thurmond RL. Histamine H4 receptor antagonists are superior to traditional antihistamines in the attenuation of
experimental pruritus. J Allerg Clin Immunol. 2007; 119(1):176-183.
Van Ganse E, Kaufman L, Derde MP, Yernault JC, Delaunois L, Vincken W. Effects of antihistamines in adult asthma: a meta-analysis of clinical trials. Eur Resp J. 1997; 10(10):2216-2224.
Mendelson WB, Roth T, Cassella J, Roehrs T, Walsh JK, Woods JH. The treatment of chronic insomnia: drug indications, chronic use and abuse liability. Summary of a 2001 new clinical drug evaluation unit meeting symposium. Sleep Med Rev. 2004; 8(1):7-17.
Csiernik R. The Essential Guide to Psychoactive Drugs in Canada: A Resource for Counselling Professionals, 2ndEdition; Canad Schol’ Press. 2019; 7-9p.
Gami-Yilinkou R, Nasal A, Kaliszan R. Application of chemometrically processed chromatographic data for pharmacologically relevant classification of antihistamine
drugs. J Chrom A. 1993; 633(1-2):57-63.
Pearlman DS. Antihistamines: pharmacology and clinical use. J Drugs. 1976; 12(4):258-273.
Mescheder A, Karrasch M, inventors; Medigene AG, assignee. Method of administering a cationic liposomal preparation. United States patent US 9,233,094. 2016; 5-14.
Gray SL, Anderson ML, Dublin S, Hanlon JT, Hubbard R, Walker R. Cumulative use of strong anticholinergics and incident dementia: a prospective cohort study. JAMA Int
Med. 2015; 175(3):401-407.
Nebreda AD, Zappia CD, González AR, Sahores A, Sosa M, Burghi V, Monczor F, Davio C, Fernández N, Shayo C. Involvement of histamine H1 and H2 receptor inverse
agonists in receptor's crossregulation. Eur J Pharm. 2019; 847:42-52.
Wang T, Fu H, Kaminga AC, Li Z, Guo G, Chen L, Li Q. Prevalence of depression or depressive symptoms among people living with HIV/AIDS in China: a systematic review
and meta-analysis. BMC Psy. 2018; 18(1):1-4.
Simons FER and Simons KJ. Histamine and H1-antihistamines: Celebrating a century of progress. J Allerg Clin Immunol. 2011; 128(6):1139-50.
Schempp CM, Schauer F, Huhn CK, Venhoff N, Finzel S. Skin inflammation associated with arthritis, synovitis and enthesitis. Part 2: rheumatoid arthritis, reactive arthritis,
Reiter's syndrome, Lyme borreliosis, dermatomyositis and lupus erythematosus. JDDG. J der Deut Derm Gese. 2019; 17(2):167-181.
Simons FER. Advances in H1-antihistamines. New Eng J Med. 2004; 351(21): 2203-2217.
Stahn C, Löwenberg M, Hommes DW, Buttgereit F. Molecular mechanisms of glucocorticoid action and selective glucocorticoid receptor agonists. Mol Cell Endocrinol. 2007; 275(1-2):71-78.
Fu XQ, Cai JY, Li MJ. Prednisone may rebuild the immunologic homeostasis: Alteration of Th17 and Treg cells in the lymphocytes from rats' spleens after treated with prednisone‐containing serum. Mol Gene Geno Med. 2019; 7(7):e00800.
Veeraswami B and Naveen V. Development and validation of rp-hplc method for the estimation of dolutegravir and rilpivirine in bulk and pharmaceutical dosage form and its application to rat plasma. Dev. 2019; 12(2):267-271