ANALYTICAL METHOD DEVELOPMENT, VALIDATION AND STABILITY STUDIES BY RP-HPLC METHOD FOR SIMULTANEOUS ESTIMATION OF ANDROGRAPHOLIDE AND CURCUMIN IN CO-ENCAPSULATED NANOSTRUCTURED LIPID CARRIER DRUG DELIVERY SYSTEM
DOI:
https://doi.org/10.22159/ijap.2021v13i5.42181Keywords:
Andrographolide, Curcumin, Nanoformulation, RP-HPLC method development, Forced degradationAbstract
Objective: The current study aims to boost the bioavailability criteria of two natural bioactive compounds, andrographolide and curcumin by their combination in nanostructured lipid carrier (NLC) and also to develop a straightforward reverse-phase high-performance liquid chromatography (RP-HPLC) method to validate, quantify of andrographolide and curcumin simultaneously in novel NLC formulation.
Methods: The reliable chromatographic separation was executed by using a column of Phenomenex octadecylsilane (C18) at 35 °C column oven temperature using a mobile phase of 0.02 M potassium dihydrogen orthophosphate (KH2PO4) salt solution of pH 3.0 as a buffer and acetonitrile in 50: 50 v/v fixed ratio and 1.5 ml/min flow rate of with 20 μl injection load. The detection was carried out at 240 nm isosbestic wavelength employing a photodiode array (PDA) detector.
Results: Andrographolide and curcumin were eluted at 2.4 and 4.9 min, respectively. Quantification and linearity were achieved for both drugs at the 10-140 μg/ml range. The method is specified as the presence of excipients utilized in the formulation failed to interfere with the estimation of andrographolide and curcumin. The developed method was successfully utilized to work out the drug loading efficiency and in vitro drug release study of those drugs in NLC formulation and also for the estimation of those drugs from rat plasma.
Conclusion: The developed high-performance liquid chromatography (HPLC) method may be utilized in the future estimation of andrographolide and curcumin simultaneously in NLC and other nanoformulations both in vitro and in vivo.
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Chaudhari VK, Pathak D, Hussain Z, Kumar P, Yadav V. Importance of herbal drug for new drug development. J Appl Pharm Sci Res 2018;1:19-22.
Yuting C, Rongliang Z, Zhongjian J, Yong J. Flavonoids as superoxide scavengers and antioxidants. Free Radical Biol Med 1990;9:19–21.
Cushnie TPT, Lamb AJ. Antimicrobial activity of flavonoids. Int J Antimicrob Agents 2005;26:343-56.
Yao LH, Jiang YM, Shi J, Tomas Barberan FA, Datta N, Singanusong R, Chen SS. Flavonoids in food and their health benefits. Plant Foods Hum Nutr 2004;59:113-22.
Kesarwani K, Gupta R. Bioavailability enhancers of herbal origin: an overview. Asian Pac J Trop Biomed 2013;3:253–66.
Patarapanich C, Laungcholatan S, Mahaverawat N, Chaichantipayuth C, Pummangura S. HPLC determination of active diterpene lactones from Andrographis paniculata nees planted in various seasons and regions in Thailand. Thai J Pharm Sci 2007;31:91-9.
Qizhen D, Jerz G, Winterhalter P. Separation of andrographolide and neoandrographolide from the leaves of Andrographis paniculata using high-speed counter-current chromatography. J Chromatogr 2003;984:147-51.
Balachandran P, Govindarajan R. Cancer-an ayurvedic perspective. Pharmacol Res 2005;51:19-30.
Fitrawan LOM, Ariastuti R, Tjandrawinata RR, Nugroho AE, Pramono S. Antidiabetic effect of a combination of fractionated-extracts of Andrographis paniculata and centella asiatica: in vitro study. Asian Pac J Trop Biomed 2018;8:27-32.
Rao NK. Anti-hyperglycemic and renal protective activities of Andrographis paniculata roots chloroform extract. Iran J Pharmacol Ther 2006;5:47-50.
Martin RCG, Aiyer HS, Malik D, Li Y. Effect on pro-inflammatory and antioxidant genes and bioavailable distribution of the whole turmeric vs curcumin: similar root but different effects. Food Chem Toxicol 2012;50:227–31.
Chattopadhyay I, Biswas K, Bandyopadhyay U, Banerjee RK. Turmeric and curcumin: biological actions and medicinal applications. Curr Sci 2004;87:44–53.
Gupta SC, Kismali G, Aggarwal BB. Curcumin, a component of turmeric: from farm to pharmacy. BioFactors 2013;39:2–13.
Kurangi BK, Jalalpure SS. Review of selected herbal phytoconstituents for potential melanoma treatment. Indian J Health Sci Biomed Res 2018;11:3–11.
Singh CK, George J, Ahmad N. Resveratrol-based combinatorial strategies for cancer management. Ann N Y Acad Sci 2013;1290:113–21.
Shinde N, Chauhan AS, Gupta SK, Bodakhe SH, Pandey DP. Antifertility studies of curcumin and andrographolide combination in female rats. Asian Pac J Reprod 2015;4:188-94.
Mishra K, Dash AP, Dey N. Andrographolide: a novel antimalarial diterpene lactone compound from Andrographis paniculata and its interaction with curcumin and artesunate. J Trop Med 2011;10:1-6.
Mishra K, Dash AP, Swain BK, Dey N. Anti-malarial activities of Andrographis paniculata and Hedyotis corymbosa extracts and their combination with curcumin. Malar J 2009;8:1-9.
Banerjee S, Roy S, Bhaumik KN, Pillai J. Mechanisms of the effectiveness of lipid nanoparticle formulations loaded with anti-tubercular drug combinations toward overcoming drug bioavailability in tuberculosis. J Drug Target 2020;28:55-69.
Chakraborty S, Kar N, Kumari L, De A, Bera T. Inhibitory effect of a new orally active cedrol-loaded nanostructured lipid carrier on compound 48/80-induced mast cell degranulation and anaphylactic shock in mice. Int J Nanomed 2017;12:4849-68.
Akowuah GA, Zhari I, Norhayati I, Mariam A. HPLC and HPTLC densitometric determination of andrographolides and antioxidant potential of Andrographis paniculata. J Food Compos Anal 2006;19:118–26.
Li W, Fitzloff JF. Determination of andrographolide in commercial andrographis (Andrographis paniculata) products using HPLC with evaporative light scattering detection. J Liq Chromatogr Relat Technol 2002;25:1335-43.
Sharma M, Sharma A, Tyagi S. Quantitative HPLC analysis of andrographolide in Andrographis paniculata at two different stages of the life cycle of a plant. Acta Chim Pharm Indica 2012;2:1-7.
Li HX, Zhang HL, Zhang N, Wang N, Yang Y, Zhang ZZ. Isolation of three curcuminoids for stability and simultaneous determination of only using one single standard substance in turmeric color principles by HPLC with a ternary gradient system. LWT Food Sci Technol 2014;57:446-51.
Syed HK, Liew KB, Loh GOK, Peh KK. Stability indicating HPLC–UV method for detection of curcumin in Curcuma longa extract and emulsion formulation. Food Chem 2015;170:321–6.
Prabaningdyah NK, Riyanto S, Rohman A, Siregar A. Application of HPLC and response surface methodology for simultaneous determination of curcumin and desmethoxy curcumin in curcuma syrup formulation. J Appl Pharm Sci 2017;7:58-64.
Girija KS, Kasimala BB, Anna VR. A new high-performance liquid chromatography method for the separation and simultaneous quantification of eptifibatide and its impurities in pharmaceutical injection formulation. Int J Appl Pharm 2021;13:165-72.
Validation of analytical procedure: text and methodology. ICH. Q2(R1); 2005.
Gandhi SV, Mittal PS, Gaikwad AM. Development and validation of stability indicating RP-HPLC method for simultaneous estimation of beclomethasone dipropionate and salbutamol sulfate. Int J Pharm Pharm Sci 2015;7:252-7.
Korany MA, Haggag RS, Ragab MAA, Elmallah OA. A validated stability-indicating HPLC method for simultaneous determination of silymarin and curcumin in various dosage forms. Arab J Chem 2013;10:S1711-25.
Naazneen S, Sridevi A. Development of assay method and forced degradation study of valsartan and sacubitril by RP-HPLC in tablet formulation. Int J Appl Pharm 2017;9:9-15.
Koga AY, Carletto B, Lipinski LC, Klein T, Farago PV. Development and validation of a high-performance liquid chromatography method for the determination of 17-Β estradiol in polymeric nanoparticles. Asian J Pharm Clin Res 2021;14:112-6.
Sunder BS, Mittal AK. Bio-analytical method development and validation for simultaneous determination of ledipasvir and sofosbuvir drugs in human plasma by RP-HPLC method. Int J Curr Pharm Res 2018;10:21-6.
Chaudhari VS, Borkar RM, Murty US, Banerjee S. Analytical method development and validation of reverse-phase high-performance liquid chromatography (RP-HPLC) method for simultaneous quantifications of quercetin and piperine in dual-drug loaded nanostructured lipid carriers. J Pharm Biomed Anal 2020;186:113325.
Korake S, Pawar A, Surywanshi S, Bothiraja C, Pawar A. High-performance liquid chromatography for the simultaneous estimation of cefoperazone and sulbactam in rat plasma and its importance in therapeutic drug monitoring. Int J Pharm Pharm Sci 2020;12:92-7.
Xu T, Pan J, Zhao L. Simultaneous determination of four andrographolides in Andrographis paniculata nees by silver ion reversed-phase high-performance liquid chromatography. J Chromatogr Sci 2008;46:747-50.
Wichitnithad W, Jongaroonngamsang N, Pummangura S, Rojsitthisak P. A simple isocratic HPLC method for the simultaneous determination of curcuminoids in commercial turmeric extracts. Phytochem Anal 2009;20:314–9.
Ma Z, Shayeganpour A, Brocks DR, Lavasanifar A, Samuel J. High-performance liquid chromatography analysis of curcumin in rat plasma: application to the pharmacokinetics of polymeric micellar formulation of curcumin. Biomed Chromatogr 2007;21:546–52.
Singh A, Meena AK, Mishra S, Pant P, Padhi MM. Studies on standardization of Andrographis paniculata nees and identification by HPTLC using andrographolide as a marker compound. Int J Pharm Pharm Sci 2012;4:197-200.
Phattanawasin P, Burana Osot J, Sotanaphun U, Kumsum A. Stability-indicating TLC-image analysis method for determination of andrographolide in bulk drug and Andrographis paniculata formulations. Acta Chromatogr 2016;28:525–40.
Suneetha A, Manasa K. Development and validation of a visible spectrophotometric method for determination of andrographolide in Karmen plant extract. Asian J Pharm Anal 2014;4:85-8.
Lomlim L, Jirayupong N, Plubrukarn A. Heat accelerated degradation of solid-state andrographolide. Chem Pharm Bull 2003;51:24-6.
Ma Z, Shayeganpour A, Brocks DR, Lavasanifar A, Samuel J. High-performance liquid chromatography analysis of curcumin in rat plasma: application to the pharmacokinetics of polymeric micellar formulation of curcumin. Biomed Chromatogr 2007;21:546–52.
Wichitnithad W, Jongaroonngamsang N, Pummangura S, Rojsitthisak P. A simple isocratic HPLC method for the simultaneous determination of curcuminoids in commercial turmeric extracts. Phytochem Anal 2009;20:314–9.
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