ANALYSIS OF THREE CARDIOVASCULAR DRUGS IN THEIR TERNARY MIXTURE USING GREEN ANALYTICAL METHODOLOGY OF SMART SPECTROPHOTOMETRIC METHODS AND RP-HPLC METHOD
Keywords:
Fourier Function, Double divisor Fourier function ratio spectra, Spectrophotometry, RP-HPLC, Spiked plasmaAbstract
Objective: Development and validation of two new, simple and specific analytical techniques for the simultaneous determination of a ternary mixture of co-administered cardiovascular drugs ticagrelor (TICA), irbesartan (IRB) and hydrochlorothiazide (HCT).
Methods: Chemometric assisted UV spectrophotometric methods (considered as green analytical chemistry) and RP-HPLC method were developed and validated. The different applied chemometric methods are based on Fourier function convolution (FF) and Double divisor ratio spectra Fourier function (FFR). As for the HPLC method, it was developed on a C18 Sunfire© waters column with a mobile phase composed of Acetonitrile: sodium dihydrogen phosphate (adjusted to pH 3.6 using orthophosphoric acid) in the ratio of 60:40 v/v at a flow rate of 1 ml/min. Quantification was based on measuring peak areas at 230 nm.
Results: By applying the chemometric assisted methods, good percentage recoveries were obtained in quantifying each of the drugs in their triple mixture. The RP-HPLC method, peaks were well resolved with retention times 4.6, 8.0 and 10.0 min, for HCT, TICA and IRB, respectively. The established method was also applied in samples spiked with plasma; the peaks were well separated from each other and from plasma protein peaks, proving the ability of the HPLC method to be applied in biological samples. The methods (RP-HPLC and chemometric assisted methods) were validated in terms of linearity, LOD, LOQ, precision and accuracy. The results obtained from the analysis of the co-administered mixture by the proposed chemometric assisted methods were statistically compared to those obtained by the applied RP-HPLC method.
Conclusion: The applied RP-HPLC methods were proved to be more sensitive when compared to the applied chemometric methods, thus could be used for determination of drug concentration in human plasma. However, the applied chemometric methods, considered as green analytical chemistry, is a simple, time-saving method that requires minimal use of a hazardous solvent.Â
Downloads
References
John Wiley, Sons. Ltd E. Handbook of Green Analytical Chemistry; 2012.
Charles L, Lora A, Morton G, Leonard L. Drug Information Handbook, edition. Twelfth; 2005.
Ramakrishna VS, Rambabu C. Visible Spectrophotometric methods for the determination of irbesartan in pharmaceutical formulations. Int J Pharm Pharm Sci 2012;3 Suppl 4:86.
Baskararaju VLA. Validated RP-HPLC method for the estimation of irbesartan in bulk and tablet dosage form. Int J Res Pharm Chem 2011;1:25–8.
Jain P, Bhardwaj YR, Kishore D. Irbesartan: A review on analytical method and its determination in pharmaceuticals and biological matrix; 2014. p. 1–8.
Patel KR, Patel SA, Darji V. CSRN simultaneous spectrophotometric estimation of irbesartan and hydrochlorothiazide in tablets. Int Res J Pharm 2011;2:202–7.
Raja B, Himasri P, Ramadevi B. RP-HPLC method for the simultaneous estimation of irbesartan and hydrochlorthiazide in pharmaceutical dosage form. Int Res J Pharm Appl Sci 2012;2:29–38.
Elshanawane AA, Abdelaziz LM, Kamal MM, Hafez HM. Quantitative determination of four angiotensin-ii-receptor antagonists in presence of hydrochlorothiazide by a gradient technique HPLC in their pharmaceutical preparations. J Liq Chromatogr Relat Technol 2013;37:171–86.
Zorica Vujić, Nedžad Mulavdić, Miralem Smajić JB, Stankovic P. Simultaneous analysis of irbesartan and hydrochlorothiazide: an improved HPLC method with the aid of chemometric protocols. Molecules 2012;17:3461–74.
Peeyush Jain, Bhardwaj YR, Kishore D. A liquid chromatography tandem mass spectrometry-based method for the simultaneous determination of irbesartan and hydrochlorothiazide in human plasma. J Drug Dev Res 2013;5:169–73.
Hammouda MEA, El-enin MAA, El-sherbiny DT, El-wasseef DR, El-ashry SM. Simultaneous determination of irbesartan and hydrochlorothiazide in pharmaceutical preparations and spiked human plasma using microemulsion liquid. Int J Adv Pharm Res 2013;4:1944–59.
G Kumara Swamy, JMR Kumar JVLNSR. A validated reverse phase HPLC method for the simultaneous estimation of irbesartan and amlodipine in pharmaceutical dosage form. World J Pharm Pharm Sci 2014;3:996–1007.
Virani P, Sojitra R, Raj H. Chromatographic method for irbesartan and its combination with other drug. J Crit Rev 2015;2015;2:4–8.
Hapse SA, Wagh VS, Kadaskar PT, Dokhe MD, Shirsath AS. Spectrophotometric estimation and validation of hydrochlorothiazide in tablet dosage forms by using different solvents. Pharm Chem 2012;4:10–4.
Bhagwate S, Gaikwad NJ. Stability indicating HPLC method for the determination of hydrochlorothiazide in pharmaceutical dosage form. J Appl Pharm Sci 2013;3:88–92.
Bhatia R, Katoch S, Kumar D. Review article determination of hydrochlorothiazide and drugs in its combination. HPLC 2015;7:184–90.
Sivasubramanian L, Ks L. Spectrophotometric multicomponent analysis of telmisartan, hydrochlorothiazide and ramipril in pharmaceutical formulations by chemometric. World J Pharm Pharm Sci 2015;4:536–50.
Khadiga M Kelani, Abdallah A Shalaby, Magda Y Elmaamly MKH. Spectrophotometric and chemometric methods for simultaneous determination of two anti-hypertensive drugs in their combined dosage form. Pharm Anal Acta 2015;6:2153–435.
Santhana Lakshmi K, Lakshmi S. Simultaneous analysis of losartan potassium, amlodipine besylate, and hydrochlorothiazide in bulk and in tablets by high-performance thin layer chromatography with UV-absorption densitometry. J Anal Methods Chem 2012. Doi:10.1155/2012/108281. [Article in Press]
Pandya D, Patel M, Ghediya R, Shah A, Khunt R. Research article UV-Vis spectrophotometric assay determination of oral antiplatelet ticagrelor drug in the pharmaceutical formulation. Appl Content Uniformity 2016;8:316–21.
Kalyani L, Rao AL. UV-Vis spectrophotometric assay determination of oral antiplatelet ticagrelor drug in the pharmaceutical formulation. Appl Content Uniformity 2013;3:634–42.
Sillén H, Cook MDP. Determination of ticagrelor and two metabolites in plasma samples by liquid chromatography and mass spectrometry. J Chromatogr B: Anal Technol Biomed Life Sci 2010;25:2299–306.
Sillen H, Cook MDP. Determination of unbound ticagrelor and its active metabolite (AR-C124910XX) in human plasma by equilibrium dialysis and LC-MS/MS. J Chromatogr B 2011;879:2315–22.
Kale P, Agrawal Y, Soni G, Patel P. Simultaneous quantification of ticagrelor and its metabolite deshydroxyethoxy ticagrelor in human plasma by ultra-performance liquid chromatography electrospray ionization-tandem mass spectrometry. World J Pharm Sci 2015;3:37–45.
Validation of Analytical Procedures: Text and Methodology. International Conference on HarmonisationI CH Harmonised Tripartite Guideline. Q2(R1). Geneva; 1996.
AM Wahbi, H Abdine MK. Changes in the expression of hepatic cytochrome P450 isoenzymes 2E1, 2B1/2, 4A, and 2C6 IN mice infected with different levels of schistosoma mansoni cercariae. Pharmazie 2005;278:14–33.
Mohamed A Korany, Mahmoud A Elsayed, Mona M Bedair, Hoda Mahgoub, Ezzat A Korany. Computer-assisted spectrophotometry: Multicomponent analysis with a discrete fourier transform. Talanta 1990;37:1183–8.
FDA Center for Drug Evaluation Research (CDER), Reviewer Guidance: Validation of Chromatographic Methods, Washington, USA; 1994.
Miller JN, Mileer JC. Statistics and chemometrics for analytical chemistry. 5th ed. London, Pearson Prentice Hall; 2005.
P Berry G. Statistical methods in medical research. Armitage Black Well, Oxford, UK; 2001. p. 832.