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Current Pharmaceutical Analysis

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ISSN (Print): 1573-4129
ISSN (Online): 1875-676X

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Research Article

Compatibility Determination of Drug-Polymer, Drug-Excipient & Drug-Intravenous Admixtures Using Chemometric-assisted UVspectrophotometry

Author(s): Amir Ibrahim Mohamed*, Amal Abd-Elaal El-Khamery, Mohamed Ismail Herry and Alaa Ibrahim Mohamed

Volume 16, Issue 2, 2020

Page: [125 - 142] Pages: 18

DOI: 10.2174/1573412914666181011142351

Price: $65

Abstract

Purpose: A new multivariate chemometric approach was developed for fast and economic compatibility determinations of ranitidine hydrochloride (as model drug) with certain pharmaceutical; polymers (Alginate & Chitosan), excipient (Lactose) and intravenous fluids (Dextrose, Ringer & Dextrose/ Ringer). Binary mixtures of the drug and each item were prepared and investigated by chemometric- assisted UV- spectrophotometry as well as by HPLC reference method.

Methods: Five drug concentration levels (0.004-0.025mg/ml) of test-mixtures were used and the average drug recovery percent after two and seven days of storage from initial concentration was determined. Physico-chemical techniques including DSC, XRD, & FTIR were also performed to investigate the nature of the observed drug-additive interactions.

Results: UV-chemometric and HPLC results showed that ranitidine stability in mixture aqueous solutions appears to be concentration dependent. The ranitidine content remained greater than 90% in alginate & chitosan test mixtures at all used drug concentrations (0.004-0.025mg/ml), while in lactose, dextrose, ringer & dextrose/ringer test mixtures fell below 90% at low drug concentrations (0.004- 0.009mg/ml), which suggests more ranitidine compatibility with alginate & chitosan rather than the other additives.

Conclusion: The developed chemometric method, employing UV absorbance data successfully used as simple, rapid, and economic alternative tool in drug-additive compatibility determinations.

Keywords: Ranitidine hydrochloride, drug-Polymer compatibility, drug-excipient compatibility, drug-intravenous admixtures compatibility, UV-chemometric, HPLC.

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[1]
Singh, I.; Juneja, P.; Kaur, B.; Kumar, P. Pharmaceutical Applications of chemometric techniques. ISRN Anal. Chem., 2013, 1-13.
[2]
Florey, K. Analytical Profiles of Drug Substances; vol. 15.;Academic Press. , 1986.
[3]
Sarisuta, N.; Lawanprasert, P.; Puttipipatkhachorn, S.; Srikummoon, K. The influence of drug-excipient and drug-polymer interactions on butt adhesive strength of ranitidine hydrochloride film-coated tablets. Drug Dev. Ind. Pharm., 2006, 32(4), 463-471.
[4]
Yehia, A.M.; Sami, I.; Riad, S.M.; El-Saharty, Y.S. Qualitative and quantitative chemometry as stability-indicating methods for determination of dantrolene sodium and paracetamol. Curr. Pharm. Anal., 2017, 14(1), 60-67.
[5]
Gholivand, M-B.; Jalalvand, A.R.; Goicoechea, H.C.; Skov, T. Chemometrics-assisted simultaneous voltammetric determination of ascorbic acid, uric acid, dopamine and nitrite: application of non-bilinear voltammetric data for exploiting first-order advantage. Talanta, 2014, 119, 553-563.
[6]
Bhaskar, R.; Bhaskar, R.; Sagar, M.K.; Saini, V. Multivariate chemometric assisted analysis of metformin hydrochloride, gliclazide and pioglitazone hydrochloride in bulk drug and dosage forms. Adv. Pharm. Bull., 2013, 3(1), 79-84.
[7]
Issa, M.M.; Nejem, R.M.; Abu Shanab, A.; Stefan-van Staden, R-I. Resolution of ternary mixture of aspirin, atorvastatin, and clopidogrel by chemometric-assisted uv spectroscopic and liquid chromatography methods. Int. J. Spectrosc., 2013, 2013, 1-8.
[8]
Daharwal, S.J.; Singh, V.D. Estimation of binary mixtures of captopril and hydrochlorthiazide by using chemometric assisted method. Asian J. Pharm. Technol., 2015, 5(2), 79.
[9]
De Luca, M.; Ioele, G.; Spatari, C.; Ragno, G. Optimization of Wavelength Range and Data Interval in Chemometric Analysis of Complex Pharmaceutical Mixtures; , 2016, Vol. 6, .
[10]
Saadat, A.; Pourbasheer, E.; Morsali, S.; Aalizadeh, R. Simultaneous spectrophotometric determination of aspirin and dipyridamole in pharmaceutical formulations using the multivariate calibration methods. Curr. Pharm. Anal., 2018, 14(4), 419-425.
[11]
Mohamed, A.; Abd-Motagaly, A.; Ahmed, O.; Amin, S.; Mohamed Ali, A. Investigation of drug-polymer compatibility using chemometric-assisted UV-spectrophotometry. Pharmaceutics, 2017, 9(1), 7.
[12]
Jamrógiewicz, M.; Łukasiak, J. Short term monitor of photodegradation processes in ranitidine hydrochloride observed by FTIR and ATR-FTIR. J. Food Drug Anal., 2009, 17(5), 342-347.
[13]
Jha, S.K.; Karki, R.; Sajeev, B.; Venkatesh, D.P. Development and evaluation of ground nut oil based microemulsion., 2014, 4(2), 1029-1039.
[14]
Prosenjit, M.; Anindya, B.; Anusree, R. Simultaneous Determination and method validation of ranitidine hydrochloride and itopride hydrochloride by UV-spectrophotometery. Afr. J. Pharm. Pharmacol., 2015, 9(33), 834-842.
[15]
Skb, N.R.; Smt, N.K. Studies on the physico-chemical interaction of ranitidine with excipients studies on the physico-chemical interaction of ranitidine with excipients., 2013, 5, 32-39.
[16]
Stewart, J.T.; Warren, F.W.; Johnson, S.M.; Galante, L.J. Stability of ranitidine in intravenous admixtures stored frozen, refrigerated, and at room temperature. Am. J. Hosp. Pharm., 1990, 47(9), 2043-2046.
[17]
Galante, L.J.; Stewart, J.T.; Warren, F.W.; Johnson, S.M.; Duncan, R. Stability of ranitidine hydrochloride at dilute concentration in intravenous infusion fluids at room temperature. Am. J. Hosp. Pharm., 1990, 47(7), 1580-1584.
[18]
Kamble, M.S.; Mane, O.R.; Borwandkar, V.G.; Mane, S.S.; Chaudhari, P.D.; College, P.E.S.M. Formulation and evaluation of clindamycin HCL - chitosan microspheres for dry powder inhaler formulation. Drug Invent. Today, 2012, 4(10), 527-530.
[19]
Damiani, P.; Escandar, G.; Olivieri, A.; Goicoechea, H. Multivariate calibration: a powerful tool in pharmaceutical analysis. Curr. Pharm. Anal., 2005, 1(2), 145-154.
[20]
Nair, R.; Nyamweya, N.; Gönen, S.; Martínez-Miranda, L.J.; Hoag, S.W. Influence of various drugs on the glass transition temperature of Poly(Vinylpyrrolidone): A thermodynamic and spectroscopic investigation. Int. J. Pharm., 2001, 225(1-2), 83-96.
[21]
Mohamed, A.I.; Ahmed, O.A.A.; Amin, S.; Elkadi, O.A.; Kassem, M.A. In-vivo evaluation of clindamycin release from glyceryl monooleate-alginate microspheres by NIR spectroscopy. Int. J. Pharm., 2015, 494(1), 127-135.
[22]
Alahmad, S.; Elfatatry, H.M.; Mabrouk, M.M.; Hammad, S.F.; Mansour, F.R. Development and validation of chemometric spectrophotometric methods for simultaneous determination of simvastatin and nicotinic acid in binary combinations. Curr. Drug Discov. Technol., 2018, 15(2), 149-155.
[23]
Riahi, S.; Ganjali, M.; Pourbasheer, E.; Divsar, F.; Norouzi, P.; Chaloosi, M. Development and validation of a rapid chemometrics-assisted spectrophotometry and liquid chromatography methods for the simultaneous determination of the phenylalanine, tryptophan and tyrosine in the pharmaceutical products. Curr. Pharm. Anal., 2008, 4(4), 231-237.
[24]
Bharate, S.S.; Bharate, S.B.; Bajaj, A.N. Interactions and incompatibilities of pharmaceutical excipients with active pharmaceutical ingredients: A comprehensive review. J. Excip. Food Chem., 2010, 1(3), 3-26.
[25]
Teraoka, R.; Otsuka, M.; Matsuda, Y. Effects of temperature and relative humidity on the solid-state chemical stability of ranitidine hydrochloride. J. Pharm. Sci., 1993, 82(6), 601-604.
[26]
Das Gupta, V.; Parasrampuria, J.; Bethea, C. Chemical stabilities of famotidine and ranitidine hydrochloride in intravenous admixtures. J. Clin. Pharm. Ther., 1988, 13(5), 329-334.
[27]
Shrivastava, A.; Sharma, J.K.; Gutch, P. Incompatibility studies between α, α-Xylene-p-Bis-3,3(Hydroxyiminomethyl) pyridinium dibromide and 14 various commonly used excipients for the preparation of decontamination formulation against chemical warfare agents by thermoanalytical techniques. Curr. Pharm. Anal., 2012, 8(1), 107-113.
[28]
Meng, F.; Trivino, A.; Prasad, D.; Chauhan, H. Investigation and correlation of drug polymer miscibility and molecular interactions by various approaches for the preparation of amorphous solid dispersions. Eur. J. Pharm. Sci., 2015, 71, 12-24.
[29]
Shirse, P. Formulation and evaluation of bilayer tablets of diclofrenac sodium with ranitidine hcl for sustained and immediate release. J. Appl. Pharm. Sci., 2012, 2(5)

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