Pharmaceutical Analysis and Standardization of Herbal Medicines

Authors

  • Falah Shynan Alqahtani Pharmacy Technician, PSMMC, Riyadh
  • Zainab Ibrahim Alshabeb Pharmacist, PSMMC, Riyadh
  • Meshal Muflih Aljohani Pharmacy Technician, PSMMC, Riyadh
  • Nahla Faleh Alotaibi Pharmacy Technician, PSMMC, Riyadh
  • Abdulrahman Buzaya Alshammari Pharmacy Technician, PSMMC, Riyadh

DOI:

https://doi.org/10.29070/2415sk26

Keywords:

Standardization, Herbal, analysis, natural, Pharmaceutical

Abstract

This paper  provides a comprehensive overview of the criteria used to test and standardize medicinal plants and components in the pharmaceutical sector. Natural or herbal therapies are becoming increasingly popular as alternatives to commercially produced drugs due to their low risk of side effects. As herbal therapeutic items become more popular, concerns regarding their effectiveness, safety, and quality arise. These problems stem from the lack of herbal therapy standardization criteria. To maintain quality, herbal medicinal plant components must be standardized using rigorous standards and analytical methods. Herbal treatments are tested and standardized using several physical, chemical, and biological approaches. These methods determine if herbal plant materials and formulations are safe, pure, and effective and constitute the basis of quality control. Analytical methods like TLC, HPTLC, GC, LC-MS, UPLC, UHPLC, UPLC-MS, and UHPLC-MS are used to quantify herbal drugs and their formulations. This assessment emphasizes these methods. Standardized assessment criteria are necessary to guarantee herbal medical product active ingredients are dependable and effective. These analytical methods can standardize and test herbal medicines. This preserves herbal medicine quality and reliability. If these guidelines are followed, herbal medicines will meet safety, efficacy, and consistency criteria.

References

Agarwal, A., 2005. Critical issues in Quality Control of Herbal Products, Pharma Times, 37(6), Pp 09-11.

Sane, R.T., 2002. Standardization, Quality Control and GMP for Herbal drugs, Indian Drugs, 39 (3), 184-190.

Florey, H. W., Chain, E. and Florey, M. E., 1949. Vol. 1. The antibiotic, Oxford University Press. New York. P p. 576-628.

Zafar R, Panwar R, Sagar Bhanu PS. Herbal drug standardization: The Indian Pharmacist 2005; 4(36): 21-25.

Patra KC, Pareta SK, Harwansh RK, Jayaram Kumar K .Traditional approaches towards standardization of herbal medicines -Areview. J Pharm Sci Technol 2010; 2 (11): 372- 379.

Straus SE. Herbal remedies. New Engl J Med 2002; 347: 2046–2056.

Indian Herbal Pharmacopoeia, Indian Drug Manufacturers’ Association, Mumbai, 2002.

British Herbal Pharmacopoeia, British Herbal Medicine Association, 1996.

Quality Control Methods for Medicinal Plant Materials, WHO, Geneva, 1996.

Bhutani KK. Herbal medicines enigma and a challenge for science and guidelines for new initiatives. J Nat Prod 2003;19(1): 3-8.

Mosihuzzaman M, Choudhary MI. Protocols on safety, efficacy, standardization, and documentation of herbal medicine. Pure Appl Chem 2008; 80(10):2195–2230

Seitz U, Bonn G, Oefner P, Popp M. Isotachophoretic analysis of flavonoids and phenolcarboxylic acids of relevance to phytopharmaceutical industry. J Chromatogr 1991;559, 499-504.

O’Shea TJ .Capillary electrophoresis/electrochemistry. Curr Sep 1995;14(1): 18-23.

Svicekova M, Havranek E, Novak V. Determination of heavy metals in samples of herbal drugs using differential pulse polarography. J Pharm Biol 1993; 42(2):68-70.

Anonymous: National Health Policy. New Delhi: Ministry of Health and Family Welfare, Government of India; 1983.

indianmedicine.nic.in/writereaddata/.../2469101869- A%20to%20H.p

Pattanayak P, Behera M, Mohapatra P, Panda SK. Standardization and evaluation of laxative activity of a polyherbal formulation. Der Pharmacia Lettre 2011; 3(1): 276-286.

Patwardhan B, Warude D, Pushpangadan P, Bhatt N. Ayurveda and traditional Chinese medicine: A comparative overview. Evidence-Based Complementary and Alternative Medicine (eCAM) 2005; 2(4): 465–473.

Vijaya Kumar D, Raghavan KV. Novel chromatographic fingerprinting method for standardization of single medicines and formulations. Indian Institute of Chemical Technology, Hyderabad, WO 0246739-EP2 0000991 991- 263397CSIR G01N30-88, 2002.

Mukherjee PK, Venkatesh M, Kumar V. An overview on the development in regulation and control of medicinal and aromatic plants in the Indian System of Medicines. Bol Latinoam Caribe Plant MedAromaticas. 2007; 6(4):129- 137.

www.who.int/medicinedocs/en/d/Js4928e/; accessed 28 Nov 2011. 30. www.who.int/medicinedocs/index/assoc/s7148e/ s7148e.pdf

Government of Canada. Natural Health Products Regulations; 2009. Available at: http://laws.justice.gc.ca/ e n /s h o w t d m / c r/ S O R- 2 0 0 3 - 1 9 6 / / ? s h o w t o c = & instrumentnumber=SOR-2003-196 [accessed November 22, 2009.

http://apps.who.int/medicinedocs/en/d/Js7916e/9.5.html

Bauer R. Quality criteria and standardization of phytopharmaceuticals: Can acceptable drug standard can be achieved?.J Drug Inform 1998; 32:101-110.

Sharma AK, Gaurav SS, Balkrishna A. A rapid and simple scheme for the standardization of polyherbal drugs. Int J Green Pharm 2009; 3:134-140

Satheesh Madhav NV, Kumud Upadhyaya, Bisht A. Phytochemical screening and standardization of polyherbal formulation for dyslipidemia. Int J Pharm Pharmaceut Sci 2011;3:56-59.

Patwardhan B. Amethod of treating musculoskeletal disease and a novel composition there of. US Patent 5494668, 1996.

Chandel HS, Pathak AK, Tailang M. Standardization of some herbal antidiabetic drugs in polyherbal formulation. J Pharmacog Res 2011;3(1):49-56

Meena AK, Rao MM, Panda P, Kiran, Yadav A, Singh U, et al. Standardisation of ayurvedic polyherbal formulation, Pancasama Churna. Int J Pharmacog Phytochem Res 2010;2(1):11-14.

Sanjay J, Sweta S, Rakesh B, Praveen K. Standardization of ‘Dashamularishta’: A polyherbal formulation. Pharmacog J 2009;1(3):54-57.

Kumar T, Chandrashekar KS, Tripathi DK, Nagori K, Pure S,Agrawal S, et al. Standardization of “Gokshuradi Churna” An ayurvedic polyherbal formulation. J Chem Pharm Res 2011;3(3):742-749.

Kasthuri KT, Radha R, Jayshree N, Austin A, Shanthi P. Development of GC-MS for a poly herbal formulationMEGNI. IntJ Pharm Sci 2010;2:81-83.

Meena R, Meena AK, Khan SA, Mageswari S. Standardization of Unani polyherbal drug - Jawarish-eDarchini. J Pharm Res 2010;7(3):11-12.

Rajani M, Kanaki NS .Phytochemical standardization of herbal drugs and polyherbal formulations. Bioactive Molecules and Medicinal Plants, (Ramawat KG, Mérillon JM (Eds.) Springer 2008; 349-369.

Ahmad I, Aqil F, Owais M. Turning medicinal plants into drugs. Modern Phytomed 2006; 384:67-72

Rajurker S, Rekhe DS, Maini S, Ravikanth K. Acute toxicity studies of polyherbal formulation (Methiorep Premix). Vet World 2009; 2(2):58-59.

Wani M.S. Herbal Medicine and its Standarization.Pharma info, 5(6),2007, 1-6

Patwardhan B. Ayurveda the designer medicine: a review of ethnopharmacology and bioprospective research. Indian Drugs, 37 (5), 2000,2046-56

Dixit V.K. &Yadav.N.P. Recent approaches in herbal drug standardization. IntegrBiol,2 (3), (2008), 195-203.

Anna KD, Stephen PM. Safety issues in herbal medicine: implications for the health professions. Med J Aust166 (1997), 538-541.

Michael DR. Herbal medicine: a practical guide to safety and quality assurance. West J Med 171 (1999), 172-175.

Shinde VM, Dhalwal K, Potdar M &Mahadik KR. Application of quality control principles to herbal drugs. Int J Phytomedicine. 1(2009), 4–8

Hussain Khalid , Majeed M, Ismail Zhari, SadikunAmirin&Ibrahim Pazilah .Traditional and complementary medicines: Quality assessment strategies and safe usage ;Southern MedReview , 2 (1) (April 2009), 19-23

Quality control methods for medicinal plant materials (WHO) , Geneva, A.T.T.B.S Publishers and Distributers, Delhi. 2002

Raya Luis Gomez, Hanne Gro Olsen, FrodeLingaas, HelgeKlungland, Dag IngeVåge, Ingrid Olsaker, SeblewengelBekeleTalle, Monica Aasland, and Sigbjorn Lien. The Use of Genetic Markers to Measure Genomic Response to Selection in Livestock. Genetics. 2002,162, 1381-1388

Khanuja SPS, Shasany AK, Aruna V, Darokar MP, Kalra A, Bahl JR, Bansal, RP RAPD marking of three Pelargonium graveolens genotypes with chemotypic differences in oil quality., J. Med. Aromat. Plant Sci. 2002, 24: 729–32.

Ramakrishna W, Lagu M D, Gupta V S, Ranjekar P K., DNA fingerprinting in rice using oligonucleotide probes specific for simple repetitive DNA sequences., The Applied Genetics. 1994, 88,402-406

Lau.D. T., Shaw P. C,., Wang J., and Shaw P. C., Authentication of medicinal Dendrobium species by the internal transcribed spacer of ribosomal DNA, Planta Med.,2001, 67, 456–460

Ratnaparkhe M. B., Gupta V. S., Venmurthy M. R. and Ranjekar P. K. Genetic fingerprinting of pigeonpea (Cajanuscajan (L.) Millsp.) and its wild relatives using RAPD markers, The. Applied Genetics, 1995, 91, 893–98.

Shaw P. C. and But P. P. Authentication of Panax species and their adulterants by random-primed polymerase chain reaction. Planta Med. 61,(1995), 466–69

Harborne A.J. Phytochemical Methods A Guide to Modern Techniques of Plant Analysis. 3ed. New York; Springer Dordrecht; 1998. 110-130p.

Gong F, Liang Y, Xie P, Chau F. Information theory applied to chromatographic fingerprint of herbal medicine for quality control. J. Chromatogr. A. 2003;1002(1-2); 25-40

Wagner H, Bladt S, Rickl V. Plant Drug Analysis: A Thin Layer Chromatography Atlas. 2ed. New York; Springer Berlin, Heidelberg; 1996. 54-71p.

Brochmann-Hanssen E, Svendsen A. Gas Chromatography of Alkaloids, Alkaloidal Salts and Derivatives. J. Pharm. Sci. 1962; 51(11); 1095-1098

Soleas G, Diamandis E, Karumanchiri A, Goldberg D. A Multiresidue Derivatization Gas Chromatographic Assay for Fifteen Phenolic Constituents with Mass Selective Detection. Anal. Chem. 1997; 69(21); 4405-4409

Majlat P, Barthos E. Quantitative gas and thinlayer chromatographic determination of methyl paraben in pharmaceutical dosage forms. J. Chromatogr. A. 1984; 294; 431-435

. Molyneux R, Mahoney N, Bayman P, Wong R, Meyer K, Irelan N. Eutypa Dieback in Grapevines: Differential Production of Acetylenic Phenol Metabolites by Strains of Eutypa lata. J. Agric. Food Chem. 2002; 50(6);1393-1399

Angerosa F, D'Alessandro N, Corana F, Mellerio G. Characterization of phenolic and secoiridoid aglycons present in virgin olive oil by gas chromatography-chemical ionization mass spectrometry. J. Chromatogr. A. 1996; 736(1-2); 195-203

Bunzel M, Ralph J, Marita J, Hatfield R, Steinhart H. Diferulates as structural components in soluble and insoluble cereal dietary fibre. J Sci Food Agric. 2001; 81(7); 653-60

El-Shazly A, Tei A, Witte L, El-Domiaty M, Wink M. Tropane Alkaloids of Hyoscyamus boveanus, H. desertorum, H. muticus and H. albus from Egypt. Z. Naturforsch. 1997; 52(11-12); 729-39

Ylinen M, Naaranlahti T, Lapinjoki S, Huhtikangas A, Salonen M, Simola L et al. Tropane Alkaloids from Atropa belladonna; Part I. Capillary Gas Chromatographic Analysis. Planta Med. 1986; 52(02); 85-7

Guetens G, De Boeck G, Wood M, Maes R, Eggermont A, Highley M et al. Hyphenated techniques in anticancer drug monitoring. J. Chromatogr. A. 2002; 976(1-2); 229-38

Leung A, Gong F, Liang Y, Chau F. Analysis of the Water Soluble Constituents of Cordyceps sinensis with Heuristic Evolving Latent Projections. Anal. Lett. 2000; 33(15); 3195-3211

Gong F, Liang Y, Xu Q, Chau F. Gas chromatography–mass spectrometry and chemometric resolution applied to the determination of essential oils in Cortex cinnamomi. J. Chromatogr. A. 2001; 905(1-2); 193-205

Gong F, Liang YZ, Cui H, Chau FT, Chan BT. Determination of volatile components in peptic powder by gaschromatography – mass spectrometry and chemometric resolution. J. Chromatogr. A. 2001; 909(2); 237-247

Gong F, Liang YZ, Xu QS, Chau FT, Ng KM. Evaluation of separation quality in twodimensional hyphenated chromatography. Anal. Chim. Acta. 2001; 450(1-2); 99-114

Velasco-Negueruela A, Perez-Alonso MJ, Perez de Paz PP, Pala-Paul J, Sanz J. Analysis by gas chromatography–mass spectrometry of the essential oil from the aerial parts of Pimpinella junoniae Ceb. & Ort., gathered in La Gomera, Canary Islands Spain. J. Chromatogr. A. 2003; 1011(1-2); 241-244

Lazarowych NJ, Pekos P. Use of Fingerprinting and Marker Compounds for Identification and Standardization of Botanical Drugs: Strategies for Applying Pharmaceutical HPLC Analysis to Herbal Products. Drug Inf J. 1998; 32(2); 497-512

Li XN, Cui H, Song YQ, Liang YZ, Chau FT. Analysis of volatile fractions of Schisandra chinensis (Turcz.) Baill. using GC-MS and chemometric resolution. Phytochem Anal. 2003;14(1); 23-33

Tseng MC, Tsai MJ, Lin JH, Wen KC. GC/MS analysis on anorectics adulterated in traditional chinese medicines. J Food Drug Anal. 2020; 8(4); 315-330

Zhang H, Shen P, Cheng Y. Identification and determination of the major constituents in traditional Chinese medicine Si-Wu-Tang by HPLC coupled with DAD and ESI–MS. J. Pharm. Biomed. Anal. 2004; 34(3); 705-713

Chimezie A, Ibukun A, Teddy E, Francis O. HPLC analysis of nicotinamide, pyridoxine, riboflavin and thiamin in some selected food products in Nigeria. Afr J Pharm Pharmacol 2008; 2(2):29-36.

Saravanan J, Shajan A, Joshi NH, Varatharajan R,Valliappan K. A simple and validated RP-HPLC method for the estimation of methylcobalamin in bulk and capsule dosage form. IntJ Chem Pharm Sci 2010;1(2):323-324.

Rao Udaykumar B, Anna NP .Stability- indicating HPLC method for the determination of efavirenz in bulk drug and in pharmaceutical dosage form. Afr J Pharm Pharmacol 2009;3(12):643-650.

Anupam S, Krishan L, Handa SS. Standardization: HPLC determination of vasicine in polyherbal formulations. Pharm Biol 1992; 30(3):205-208.

Demirezer O, Karahan N, Ucakturk E, Kuruuzum-Uz A, Guvenalp Z, Kazaz C. HPLC fingerprinting of sennosides in laxative drugs with isolation of standard substances from senna leaves. J Nat Prod 2011; 5(4):261-270.

Singh DP, Govindarajan R, Rawat AKS. High-performance liquid chromatography as a tool for the chemical standardisation of Triphala an ayurvedic formulation. Phytochem Anal 2007; 19(2):164-168.

Vogel H, González M, Faini F,Razmilic I,Rodríguez J, Martín JS, et al. J Ethnopharmacol 2005; 97:97–100.

Xie P.S., Chen S.B., Liang Y.Z., Wang X.H., Tian R.T. & Roy Upton (2006). Chromatographic fingerprint analysis— a rational approaches for quality assessment of traditional Chinese herbal medicine J Chromatogr A 2006; 1112:171–

Di X, Kelvin K. C. Chan, Hei Wun Leung & Carmen W. Hui. (2003). Fingerprint profiling of acid hydrolyzates of polysaccharides extracted from the fruiting bodies and spores of Lingzhi by high-performance thin-layer chromatography. J Chromatogr A. 2003; 1018:85-95.

Soni K, Naved T. HPTLC- Its applications in herbal drug industry. The Pharma Review 2010:112-117.

Jirge SS, Tatke PA, Gabhe S. Development and validation of a novel HPTLC method for simultaneous estimation of beta-sitosterol- d-glucoside and Withaferin A. Int J Pharm Pharmaceut Sci 2011;3(Suppl 2):227-230.

Shanbhag DA, Khandagale NA. Application of HPTLC in the standardization of a homoeopathic mother tincture of Syzygium jambolanum. J Chem Pharm Res 2011; 3(1):395- 401.

Shahare MD and Mello PM .Standardization of Bacopa Monnieri and its formulations with reference to Bacoside A, by high performance thin layer chromatography. Int J Pharmacog Phytochem Res 2010; 2(4):8-12.

Priyamvada S, Srinivas Bharath MM, Pratima M. Qualitative high performance thin layer chromatography (HPTLC) analysis of cannabinoids in urine samples of Cannabis abusers. Indian J Med Res 2010; 132:201-208.

Mahadevan N, Rahul PK, Subburaju T and Suresh B .HPTLC analysis of Withaferine A from an herbal extract and polyherbal formulations. J Sep Sci 2003; 26:1707–1709.

Patel PM, Patel KN, Patel NM and Goyal RK .A HPTLC method for quantitative estimation of swetiamarin in marketed polyherbal antidiabetic formulations. Indian J Pharm Sci 2007; 69: 446-448.

Shankar K, Singh A. Standardization of polyherbal formulation: Chandanasava. Int J Res Ayur Pharm 2011; 2(2):665-669.

Li SL, Lai SF, Song JZ, Qiao CF, Liu X, Zhou Y, et al. Decocting-induced chemical transformations and global quality of Du–Shen–Tang, the decoction of ginseng evaluated by UPLC–Q-TOF-MS/MS based chemical profiling approach. J Pharm Biomed Anal 2010; 53946–957.

Li SL, Song JZ, Qiao CF, Zhou Y, Qian KD, Xu HX. UPLC– PDA–TOFMS based chemical profiling approach to rapidly evaluate chemical consistency between traditional and dispensing granule decoctions of traditional medicine combinatorial formulae.J Pharm BiomedAnal 2010; 52:468– 478.

Liang YZ, Xie PS, Chan K. Chromatographic fingerprinting and metabolomics for quality control of TCM. Comb Chem High Throughput Screen 2010; 13(10):943-953.

Downloads

Published

2025-01-01

How to Cite

[1]
“Pharmaceutical Analysis and Standardization of Herbal Medicines”, JASRAE, vol. 22, no. 01, pp. 187–206, Jan. 2025, doi: 10.29070/2415sk26.

How to Cite

[1]
“Pharmaceutical Analysis and Standardization of Herbal Medicines”, JASRAE, vol. 22, no. 01, pp. 187–206, Jan. 2025, doi: 10.29070/2415sk26.