Validated green spectroscopic manipulation of area under the curve (AUC) for estimation of Simvastatin: Application to nano-structured lipid carriers and niosomal systems

Year 2023, Volume: 27 Issue: 1, 30 - 42, 28.06.2025

İslam Mannaa Omaima N. El Gazayerly Aly A. Abdelbary Sarah Saleh , Dalia A. Mostafa

Abstract

This work introduced a green spectrophotometric method based on the manipulation of the area under the curve named Area under the curve correction method (AUCCM). The method was applied for the characterization and evaluation the in-vitro release of two nanocarrier systems namely, nano-structured lipid carrier (NLC) and niosomal system of Simvastatin (SIM), through measuring free SIM in presence of the possible excipients/interferents (oleic acid and cholesterol) in a challenging matrix. The estimation of SIM was calculated using the area under the curve (AUC) in the wavelength range of (234.5 - 245.5) nm which includes the λmax of SIM in the concentration range of (1-35 µg/mL). The method was validated in compliance with ICH guidelines. The greenness of the developed analytical method will be assessed and compared to other reported methods using the greenness assessment tools known as: National Environmental Methods Index (NEMI), Green Analytical Procedure Index (GAPI) and Eco-Scale. The method proved to be the best regrading greenness and and was successfully applied for the in-vitro release study of SIM from the two nano carrier systems.

Keywords

Niosome , Nano-structured lipid carrier , Area under the curve , Green Analytical Procedure Index , Eco-scale

References

• [1] Moffat AC, Osselton DM, Widdop B, Galichet LY. Clarke's analysis of drugs and poisons. Pharmaceutical Press, London 2005.
• [2] Sweetman SC. Martindale: The complete drug reference. Pharmaceutical Press, London 2005.
• [3] Davignon J. Beneficial cardiovascular pleiotropic effects of statins. Circulation 2004; 109(23)suppl 1: III-39-III-43. [CrossRef]
• [4] Kavalipati N, Shah J, Ramakrishan A, Vasnawala H. Pleiotropic effects of statins. Indian J Endocrinol Metab 2015; 19(5): 554-562. [CrossRef]
• [5] Paraskevas KI. Statin treatment for rheumatoid arthritis: A promising novel indication. Clin Rheumatol 2008; 27(3): 281-287. [CrossRef]
• [6] Frykberg RG, Banks J. Challenges in the treatment of chronic wounds. Advances in wound care 2015; 4(9): 560-582. [CrossRef]
• [7] Delan WK, Zakaria M, Elsaadany B, ElMeshad AN, Mamdouh W, Fares AR. Formulation of simvastatin chitosan nanoparticles for controlled delivery in bone regeneration: Optimization using box-behnken design, stability and in vivo study. Int J Pharm 2020; 577: 119038. [CrossRef]
• [8] Zocor ® tablets (MERCK & CO). Https://www.Accessdata.Fda.Gov/drugsatfda_docs/label/2011/019766s077s082lbl.Pdf.
• [9] Patil P, Patil V, Paradkar A. Formulation of a self-emulsifying system for oral delivery of simvastatin: In vitro and in vivo evaluation. Acta pharmaceutica (Zagreb, Croatia) 2007; 57(1): 111-122. [CrossRef]
• [10] Verma M, Nanda A, Kumar Y. Self-emulsifying drug delivery system of simvastatin: Formulation development, optimization by box- behnken design, in-vitro and in-situ single-pass intestinal perfusion (spip) studies. Recent Pat Drug Delivery Formulation 2018; 12(3): 199-211.
• [11] Ahmed OA, Hosny KM, Al-Sawahli MM, Fahmy UA. Optimization of caseinate-coated simvastatin-zein nanoparticles: Improved bioavailability and modified release characteristics. Drug Des, Dev Ther 2015; 9: 655-662. [CrossRef]
• [12] Fattahi A, Karimi-Sabet J, Keshavarz A, Golzary A, Rafiee-Tehrani M, Dorkoosh FA. Preparation and characterization of simvastatin nanoparticles using rapid expansion of supercritical solution (ress) with trifluoromethane. J Supercrit Fluids 2016; 107: 469-478. [CrossRef]
• [13] Krishnam Raju K, Sudhakar B, Murthy KVR. Factorial design studies and biopharmaceutical evaluation of simvastatin loaded solid lipid nanoparticles for improving the oral bioavailability. Int Scholarly Res Not 2014; 951016. [CrossRef]
• [14] El-Maghraby GM, Abdelzaher MM. Formulation and evaluation of simvastatin buccal film. J Appl Pharm Sci 2015; 5(4): 70-77.
• [15] Rao NR, Laharika M, Kistayya C. Design and development of simvastatin gastroretentive tablets for controlled release. J Drug Delivery Ther 2017; 7(1): 30-36. [CrossRef]
• [16] Tulbah AS, Ong HX, Morgan L, Colombo P, Young PM, Traini D. Dry powder formulation of simvastatin. Expert Opin Drug Delivery 2015; 12(6): 857-868. [CrossRef]
• [17] Munir A, Ahmad M, Malik MZ, Minhas MU. Analysis of simvastatin using a simple and fast high performance liquid chromatography-ultra violet method: Development, validation and application in solubility studies. Trop J Pharm Res 2014; 13(1): 135-139.
• [18] Guzik L, Mrozik W, Kamysz W. Determination of simvastatin in pharmaceutical dosage forms by optimized and validated method using HPLC/UV. Croat Chem Acta 2010; 83(4): 371-377.
• [19] Nováková L, Šatínský D, Solich P. HPLC methods for the determination of simvastatin and atorvastatin. TrAC, Trends Anal Chem 2008; 27(4): 352-367. [CrossRef]
• [20] Silva TD, Oliveira MA, de Oliveira RB, Vianna-Soares CD. Development and validation of a simple and fast HPLC method for determination of lovastatin, pravastatin and simvastatin. J Chromatogr Sci 2012; 50(9): 831-838. [CrossRef]
• [21] Dixit RP, Barhate CR, Padhye SG, Viswanathan CL, Nagarsenker MS. Stability indicating RP-HPLC method for simultaneous determination of simvastatin and ezetimibe from tablet dosage form. Indian J Pharm Sci 2010; 72(2): 204-210.
• [22] Tharpa K, Basavaiah K, Rajedraprasad N, Vinay KB, Hiriyanna SG. Sensitive spectrophotometric assay of simvastatin in pharmaceuticals using permanganate. Braz J Pharm Sci 2010; 46(1): 91-98. [CrossRef]
• [23] Sharaf El-Din MM, Attia KA, Nassar MW, Kaddah MM. Colorimetric determination of simvastatin and lovastatin in pure form and in pharmaceutical formulations. Spectrochim Acta, Part A 2010; 76(4): 423-428. [CrossRef]
• [24] S Bhatia M, D Jadhav S, P Dhavale R, B Choudhari P. Rational design of colorimetric reagent for sensitivity and selectivity enhancement for β hydroxy acid of simvastatin. Lett Org Chem 2013; 10(7): 496-501.
• [25] Dey S, Pradhan PK, Upadhayay U, Patel C, Lad B. Method development and validation of simvastatin by uv spectrophotometric method. J Pharm Res 2012; 5(12): 5380-5382.
• [26] Arayne MS, Sultana N, Hussain F, Ali S. Validated spectrophotometric method for quantitative determination of simvastatin in pharmaceutical formulations and human serum. J Anal Chem 2007; 62(6): 536-541. [CrossRef]
• [27] Dhole SM, Yeole MP. First derivative UV-spectrophotometric method for simultaneous determination of simvastatin and ezetimibe in tablet dosage form. Der Pharm Lett 2015; 7: 124-128.
• [28] Lotfy HM. Determination of simvastatin and ezatimibe in combined tablet dosage forms by constant center spectrphotometric method. Int J Pharm Pharm Sci. 2012; 4(4): 673-679.
• [29] Alahmad S, Elfatatry HM, Mabrouk MM, Hammad SF, Mansour FR. Development and validation of chemometric spectrophotometric methods for simultaneous determination of simvastatin and nicotinic acid in binary combinations. Curr Drug Discovery Technol 2018; 15(2): 149-155.
• [30] Palabiyik IM, Onur F, Yardimci C, Özaltin N. Simultaneous spectrophotometric determination of ezetimibe and simvastatin in pharmaceutical preparations using chemometric techniques. Química Nova 2008; 31(5): 1121-1124. [CrossRef]
• [31] Anastas PT, Warner JC. Green chemistry: Theory and practice. Oxford University Press; New York (USA) 1998.
• [32] Lotfy HM, Saleh SS. Testing the purity of spectral profiles: Finger-print resolution of complex matrices and extraction of absorbance signals. Spectrochim Acta, Part A 2018; 205: 160-169. [CrossRef]
• [33] Lotfy HM, Saleh SS. Investigating advanced approaches based on iso-absorptivity coefficient in unresolved spectral signals of binary mixtures. J Anal Methods Chem 2019; Article ID: 7924821. [CrossRef]
• [34] Lotfy HM, Saleh SS, Hassan NY, Salem H. Computation of geometric representation of novel spectrophotometric methods used for the analysis of minor components in pharmaceutical preparations. Spectrochim Acta, Part A 2015; 151: 628-643. [CrossRef]
• [35] Ghorpade SA, Sali MS, Kategaonkar AH, Patel DM, Choudhari VP, Kuchekar BS. Simultaneous determination of emtricitabine and tenofovir by area under curve and dual wavelength spectrophotometric method. J Chil Chem Soc 2010; 55(1): 115-117.
• [36] Abdelrahman MM. Simultaneous determination of cinnarizine and domperidone by area under curve and dual wavelength spectrophotometric methods. Spectrochim Acta, Part A 2013; 113: 291-296. [CrossRef]
• [37] Abdelrahman MM. Selective spectrophotometric methods for determination of ternary mixture with overlapping spectra: A comparative study. Spectrochim Acta, Part A 2014; 124: 389–396. [CrossRef]
• [38] Gong Z, Aldeen M, Elsner L. A note on a generalized cramer’s rule. Linear Algebra Appl 2002; 340: 253–254. [CrossRef]
• [39] British Pharmacopoeia Volume II. The Stationery Office on behalf of the Medicines and Healthcare products Regulatory Agency (MHRA), London, 2013.
• [40] Zhang Z, Bu H, Gao Z, Huang Y, Gao F, Li Y. The characteristics and mechanism of simvastatin loaded lipid nanoparticles to increase oral bioavailability in rats. Int J Pharm 2010; 394(2): 147-153. [CrossRef]
• [41] Hiremath J, Sarfaraz M, Hiremath D, Sarudkar S. Preparation and physicochemical characterization of simvastatin loaded mucoadhesive bilayered tablet. Indian Journal of Novel Drug Delivery 2009; 1(1): 18-24.
• [42] Fathi HA, Allam A, Elsabahy M, Fetih G, El-Badry M. Nanostructured lipid carriers for improved oral delivery and prolonged antihyperlipidemic effect of simvastatin. Colloids Surf, B 2018; 162: 236-245. [CrossRef]
• [43] Imran M, Shah MR, Ullah F, Ullah S, Elhissi AM, Nawaz W, Ahmad F, Sadiq A, Ali I. Glycoside-based niosomal nanocarrier for enhanced in-vivo performance of cefixime. Int J Pharm 2016; 505(2): 122-132. [CrossRef]
• [44] Salem H, Lotfy HM, Hassan NY, El-Zeiny MB, Saleh SS. A comparative study of different aspects of manipulating ratio spectra applied for ternary mixtures: Derivative spectrophotometry versus wavelet transform. Spectrochim Acta, Part A 2015; 135: 1002-1010. [CrossRef]
• [45] International Conference on Harmonization (ICH) QB. Validation of analytical procedures: Methodology, federal register. 2005; 62.
• [46] Gałuszka A, Migaszewski Z, Namieśnik J. The 12 principles of green analytical chemistry and the significance mnemonic of green analytical practices. TrAC, Trends Anal Chem 2013; 50: 78-84. [CrossRef]
• [47] Alam M, Ahmed S, Nikita, Moon G, Aqil M, Sultana Y. Chemical engineering of a lipid nano-scaffold for the solubility enhancement of an antihyperlipidaemic drug, simvastatin; preparation, optimization, physicochemical characterization and pharmacodynamic study. Artif Cells, Nanomed, Biotechnol 2018; 46(8): 1908-1919. [CrossRef]
• [48] Salem HF, Kharshoum RM, Abou-Taleb HA, Farouk HO, Zaki RM. Fabrication and appraisal of simvastatin via tailored niosomal nanovesicles for transdermal delivery enhancement: In vitro and in vivo assessment. Pharmaceutics 2021; 13(2): 138. [CrossRef]
• [49] Keith LH, Gron LU, Young JL. Green analytical methodologies. Chem rev 2007; 107(6): 2695-2708. [CrossRef]
• [50] (EPA) USEPA. Persistent, bioaccumulative, and toxic (pbt) chemicals under tsca section 6(h). USA 2019. https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/persistent-bioaccumulative-and-toxic-pbt-chemicals-under.
• [51] EPA CoFR-. Identification and listing of hazardous waste, 2016.
• [52] Raynie D, Driver J. Green assessment of chemical method. 13th Annual Green Chemistry & Engineering Conference; Maryland - USA: ASC; 2009. p. 34.
• [53] (NFPA) NFPA. List of nfpa codes & standards. 2019. https://www.nfpa.org/Codes-and-Standards/All-Codes-and-Standards/List-of-Codes-and-Standards.
• [54] Płotka-Wasylka J. A new tool for the evaluation of the analytical procedure: Green analytical procedure index. Talanta 2018; 181: 204-209. [CrossRef]
• [55] Van Aken K, Strekowski L, Patiny L. Ecoscale, a semi-quantitative tool to select an organic preparation based on economical and ecological parameters. Beilstein J Org Chem 2006; 2(1): 3-10.