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Three sensitive, times saving, precise and accurate spectrophotometric techniques have been established and confirmed for the simultaneous determination of ternary admixture of rosuvastatin calcium (ROSCa), timolol maleate (TIM) and diclofenac sodium (DICNa). Method A, first derivative of ratio spectra spectrophotometric (1st DD) which is the most simple simplest one. Using the spectrum of an aliquot of 5 μg/mL of DICNa as a divisor, ROSCa could be determined by measuring 1DD amplitudes at 239.5 and 266.5 nm for ROSCa, while TIM could be similarly determined at 307.7 and 331 nm. DICNa could be determined at 269.7 and 292 nm when 5 μg/mL aliquot of ROSCa was used as a divisor without interference. This method showed limit of detection of 0.556, 0.567 & 0.3 µg/mL and correlation coefficients of 0.9997, 0.9998 and 0.9995 for ROSCa, DICNa and TIM respectively. Method B, depends on subjecting the ratio spectra to mean centering (MCRS). The arithmetical description of this method was explained. The method was performed for the estimation of these drugs together in one run without preseparation in authentic laboratory prepared mixtures, bulk and spiked human plasma. The wave lengths 277.9, 313.1 and 333.12 nm were used for the quantitative estimation of each of the studied drugs with good correlation coefficients (0.9998, 0.997& 0.9999 and LOD of 0.297, 0.150 & 0.24 µg/mL for the studied drugs in the previously mentioned order. Method C, successive-ratio derivative spectra method (SRDS). The mathematical description of the method was explained. By using this method, ROSCa, TIM and DICNa could be determined at 264, 339 and 300 nm, respectively. Correlation coefficients were 0.9998, 0.9999 & 0.9995 and LOD values of 0.374, 0.258 & 0.769 µg/mL in the same order. The three methods were linear in the range 5-25 µg/mL. The obtained results has been statistically compared with those obtained by the published one, showing no significant difference regarding accuracy and precision at p = 0.05. The developed methods do not need sophisticated techniques or instruments, besides being sensitive, selective and eco-friendly.
European Pharmacopeia 9th edition; 2017.
Ramadan AA, Mandil H, Ghazal N. Electrochemical behavior and differential pulse polarographic determination of rosuvastatin in pure form and in pharmaceutical preparations using dropping mercury electrode. International Journal of Pharmacy and Pharmaceutical Sciences. 2014;6:128-133.
Gupta A, Mishra P, Shah K. Simple UV Spectrophotometric determination of Rosuvastatin calcium in pure form and in pharmaceutical formulations. Journal of Chemistry. 2009;6(1):89-92.
Lahare RY, Phuge AN, Gite AL, Jadhav AK. A Review on Ultraviolet Spectrophotometric Determination of Rosuvastatin Calcium in Marketed Formulation. Int J Pure App Bio Sci. 2014; 2:169-174.
Uyar B, Celebier M, Altinoz S. Spectrophotometric Determination of Rosuvastatin Calcium in Tablets. Die Pharmazie. 2007;62(6):411-413.
Pandya CB, Channabasavaraj KP, Shridhara HS. Simultaneous estimation of Rosuvastatin calcium and ezetimibe in bulk and tablet dosage form by simultaneous equation method. International Journal of ChemTech Research. 2010;2(4):2140-2144.
Pandya N, Mashru RC. Simultaneous estimation of Rosuvastatin calcium and clopidogrel bisulfate in combined pharmaceutical formulation. International Journal of Drug formulation and Research. 2012;3:40-53.
Patel B, Jadav A, Solanki H, Parmar S, Parmar V, Captain A. Development and validation of derivative spectroscopic method for the simultaneous estimation of Rosuvastatin calcium and Fenofibrate in Tablet. International Journal of Pharma Research & Review. 2013;2:1-6.
Hassouna MEM, Abdel-Mageed AI, Salem HO. Indirect oxygen flask-atomic absorption spectrometric determination of Rosuvastatin calcium. Biomedical Journal of Scientific & Technical Research. 2017; 1:1-6.
Suslu I, Celebier M, Altinoz S. Determination of Rosuvastatin in Pharmaceutical Formulations by Capillary Zone Electrophoresis. Chromatographia. 2007;1:65-72.
Beludari MH, Prakash KV, Mohan GK. RP-HPLC method for simultaneous estimation of rosuvastatin and ezetimibe from their combination tablet dosage form. International Journal of Chemical and Analytical Science. 2013;4:205–209.
Hassouna MEM, Salem HO. Stability indicating new RP-HPLC method for the determination of Rosuvastatin calcium In pure and tablets dosage forms. International Journal of Applied Pharmaceutical and Biological Research. 2017;2:11-27.
Moid M, Afzal S, Rahim N, Ali T, Iffat W, Bashir L, Naz S. High performance liquid chromatographic method validation for determination of Rosuvastatin calcium in tablet dosage forms. Pakistan journal of pharmaceutical sciences. 2018;31:1577-1582.
Haq N, Shakeel F, Alanazi F, Alshora DH, Ibrahim MA. Development and validation of a green RP-HPLC method for the analysis of rosuvastatin: a step towards making liquid chromatography environmentally benign. Green Processing and Synthesis. 2018;7:160-169.
El-Abasawi NM, Attia KA, Abo-Serie AA, Abdel-Fattah A. Simultaneous determination of rosuvastatin and propranolol by HPLC in pharmaceutical dosage form. Analytical Chemistry Letters. 2018;8:46-53.
Attimarad M, Alkadham A, Almosawi MH, Venugopala KN. Development of rapid and validated RP-HPLC method for Concurrent quantification of rosuvastatin and aspirin Form solid dosage form. Indian Journal of Pharmaceutical Education and Research. 2018;52:151-158.
Islam SH, Alauddin M, Alam F, Anwar MR, Dewan I, Islam SA. Development and validation of stability-indicating Rp-Hplc method for simultaneous estimation of rosuvastatin and glibenclamide. World Journal Of Pharmacy And Pharmaceutical Sciences.2018;7(5):22-37.
Moussa BA, Hashem HM, Mahrouse MA, Mahmoud ST. A validated RP-HPLC method for the determination of rosuvastatin in presence of sacubitril/ valsartan in rat plasma: Application to in vivo evaluation of OATP-mediated drug interaction potential between rosuvastatin and sacubitril/valsartan. Microchemical Journal. 2018;143:31-38.
Geevarghese RB, Shirolkar SV. RP-HPLC method for estimation of Rosuvastatin calcium from bulk and transdermal dosage form. International Journal of Pharmaceutical Sciences and Research. 2018;9:4875-79.
Baldut M, Bonafede SL, Petrone L, Simionato LD, Segall AI. Development and validation of a complexometric titration method for the determination of Rosuvastatin calcium in raw material. Advances in Research. 2015;5:1-8.
Sane R, Kamat S, Menon S, Inamdar SR, Mote MR. Determination of Rosuvastatin calcium in its Bulk Drug and Pharmaceutical Preparations by High-Performance Thin-Layer Chromatography. Journal of Planar Chromatography-Modern TLC. 2005;18: 194-198.
Chaudhari BG, Patel NM, Shah PB. Determination of Simvastatin, Pravastatin Sodium and Rosuvastatin calcium in tablet Dosage Forms by HPTLC. Indian Journal of Pharmaceutical Sciences. 2007;69:130-132.
Devi S, Latha EP, Guptha CNK, Ramalingam P. Development and validation of HPTLC method for estimation of Rosuvastatin calcium in Bulk and pharmaceutical dosage forms. International Journal of Pharma and Bio Sciences. 2011;2:134-140.
Purkar AJ, Balap AR, Sathiyanarayanan L, Mahadik KR. Development and validation of HPTLC method for simultaneous determination of Rosuvastatin calcium and aspirin in its pure and pharmaceutical dosage form. International Journal of Pharmacy and Pharmaceutical Sciences. 2014;6(5):704-706.
Ramadan AA, Mandil H, Alshelhawi N. Spectrophotometric determination of Rosuvastatin calcium in pure form and pharmaceutical formulations by the oxidation using Iodine and formation triiodide complex in acetonitrile. International Journal of Pharmacy and Pharmaceutical Sciences. 2014;6: 579-585.
Silva TA, Pereira GF, Filho OF, Eguiluz KI, Salazar GR. Square-wave voltammetric determination of Rosuvastatin calcium in pharmaceutical and biological fluid samples using a cathodically pretreated boron-doped diamond electrode. Diamond and Related Materials. 2015;58:103-109.
Karadas-Bakirhan N, Gumustas M, Uslu B, Ozkan SA. Simultaneous determination of amlodipine besylate and Rosuvastatin calcium in binary mixtures by voltammetric and chromatographic techniques. Ionics. 2016;2:277-288.
Abdel-Fattah A. Mathematical simultaneous determination of Rosuvastatin calcium and propranolol hydrochloride using different chemometric techniques. Innoriginal: International Journal of Sciences. 2018;5:5-9.
El-Abasawi NM, Attia KAM, Abo-Serie AAM, Morshedy S, Abdel-Fattah A. Simultaneous determination of rosuvastatin and propranolol in their binary mixture by synchronous spectrofluorimetry. Spectrochimica Acta Part A: Molecular and Biomolecular Spectroscopy. 2018;198: 322-330.
[Epub 2018 Mar 13]
Chengalva P, Parameswari AS, Reddy JP. Simultaneous quantification of travoprost and timolol maleate in pharmaceutical formulation by RP-HPLC. International Journal of Pharmaceutical Sciences and Research. 2016;7:1724-1728.
Nasir F, Iqbal Z, Khan A, Ahmad L, Shah Y, Khan AZ, Khan S. Simultaneous determination of timolol maleate, Rosuvastatin calcium and diclofenac sodium in pharmaceuticals and physiological fluids using HPLC-UV. Journal of Chromatography B. 2011;879: 3434-3443.
Hassib ST, Elkady EF, Sayed RM. Simultaneous determination of timolol maleate in combination with some other anti-glaucoma drugs in rabbit aqueous humor by high performance liquid chromatography–tandem mass spectroscopy. Journal of Chromatography B. 2016;1022:109-117.
Boiero C, Allemandi D, Longhi M, Llabot JM. RP-HPLC method development for the simultaneous determination of timolol maleate and human serum albumin in albumin nanoparticles. Journal of Pharmaceutical and Biomedical Analysis. 2015;111:186-189.
Amirjani A, Bagheri M, Heydari M, Hesaraki S. Colorimetric determination of Timolol concentration based on localized surface plasmon resonance of silver nanoparticles. Nanotechnology 2016;27: 375503.
Annapurna MM, Ganesh Ch S, Teja G R, Reddy GS. Multi component mode and derivative spectrophotometric methods for the simultaneous determination of timolol maleate and brimonidine tartrate. Advances in Research. 2018;12:S251-S 255.
Gallegos A, Peavy T, Dixon R, Isseroff RR. Development of a novel ion-pairing UPLC method with cation-exchange solid-phase extraction for determination of free timolol in human plasma. Journal of Chromatography B. 2018;1096:228- 235.
Mohammed GI, Khraibah NH, Bashammakh AS, El-Shahawi MS. Electrochemical sensor for trace determination of timolol maleate drug in real samples and drug residues using Nafion/carboxylated-MWCNTs nanocomposite modified glassy carbon electrode. Microchemical Journal. 2018; 143:474-483.
Adeyeye CM, Li PK Diclofenac Sodium, Analytical Profiles of Drug Substances. 1990;19:123-144.
Khaskheli AR, Abro K, Sherazi STH, Afridi HI, Mahesar SA, Saeed M. Simpler and faster spectrophotometric determination of diclofenac sodium in tablets, serum and urine samples. Pakistan Journal of Analytical and Environmental Chemistry. 2009;10:53-58.
Matin AA, Farajzadeh MA, Jouyban A. A simple spectrophotometric method for determination of sodium diclofenac in pharmaceutical formulations. Il Farmaco. 2005;60:855-858.
Shi J, Xu M, Tang Q, Zhao K, Deng A, Li J. Highly sensitive determination of diclofenac based on resin beads and a novel polyclonal antibody by using flow injection chemiluminescence competitive immunoassay. Spectrochimica Acta Part A: Molecular and Biomolecular Spectroscopy. 2018;191:1-7.
Darweesh SA, Khalaf HS, Al-Khalisy RS, Yaseen HM, Mahmood RM. Advancement and validation of new Derivative spectrophotometric method for individual and simultaneous estimation of Diclofenac sodium and nicotinamide. Oriental Journal of Chemistry. 2018;34(4): 2074-2082.
Thongchai W, Liawruangrath B, Thongpoon C, Machan T. High performance thin layer chromatographic method for the determination of diclofenac sodium in pharmaceutical formulations. Chiang Mai Journal of Science. 2006;33: 123-128.
Sultana N, Arayne MS, Ali SN. An Ultra-sensitive LC method for simultaneous determination of rosuvastatin, alprazolam and diclofenac sodium in API, pharmaceutical formulations and human serum by programming the detector. Journal of Analytical and Bioanalytical Techniques. 2012;3:1-6.
Alquadeib BT. Development and validation of a new HPLC analytical method for the determination of diclofenac in tablets. Saudi Pharmaceutical Journal: SPJ. 2019; 27:66-70.
Mostafavi M., Yaftian MR, Piri F, Shayani-Jam H. A new diclofenac molecularly imprinted electrochemical sensor based upon a polyaniline/reduced graphene oxide nano-composite. Biosensors and Bioelectronics. 2018;122: 160-167.
El-Wekil MM, Alkahtani SA, Ali HRH, Mahmoud AM. Advanced sensing nanomaterials based carbon paste electrode for simultaneous electrochemical measurement of esomeprazole and diclofenac sodium in human serum and urine samples. Journal of Molecular Liquids. 2018;262:495-503.
Afkhami A, Bahiraei A, Madrakian T. Gold nanoparticle/multi-walled carbon nanotube modified glassy carbon electrode as a sensitive voltammetric sensor for the determination of diclofenac sodium. Materials Science and Engineering: C. 2016;59:168-176.
Hassouna MEM, Abdelrahman MM, Mohamed MA. Novel spectrophotometric methods for simultaneous determination of Cefixime trihydrate and sodium benzoate in powder for oral suspension dosage form. Global Journal of Otolaryngology. 2017;12(4):555841.
Abdelwahab NS, Abdelrahman MM, Salama FM, Ahmed AB. Determination of dimenhydrinate and cinnarizine in combined dosage form in presence of cinnarizine impurity. European Journal of Chemistry. 2015;6:475-481.
Massart DL, Vandeginste BGM, Buydens LMC, Jong SDE, Lewi PJ, Smeyers-Verbeke J. Handbook of Chemometrics and Qualimetrics: Part A, Elsevier Science; 1997.
Afkhami A, Bahram M. Mean centering of ratio spectra as a new spectrophotometric method for the analysis of binary and ternary mixtures. Talanta. 2005;66:712-720.
Afkhami A, Bahram M. Successive ratio-derivative spectra as a new spectrophotometric method for the analysis of ternary mixtures. Spectrochimica Acta Part A: Molecular and Biomolecular Spectroscopy. 2005;61:869-877.
ICH, Q2 (R1) Validation of Analytical Procedures: Text and Methodology. International conference on harmonization, Harmonized Tripartite Guideline, Geneva, Switzerland; 2005.