Estimation of psoralen from herbal formulations containing Psoralea corylifolia using the RP‑HPLC‑DAD method and its application to a pharmacokinetic study

Sunita Shailajan, Sasikumar Menon, Ashish Singh, Mandar Mhatre, Neelam Sayed, Harshvardhan Joshi, Bhavesh Tiwari


Background: Psoralea corylifolia L. (Fabaceae, seeds) is used in many formulations for the treatment of a wide range of ailments.
Aims and Objective: To develop a reverse phase high‑performance liquid chromatography‑photodiode array detector (RP‑HPLC‑DAD) method for quantitation of psoralen from P. corylifolia and its related formulations. Materials and Methods: Separation and detection of psoralen from various herbal formulations was achieved on reversed phase Cosmosil C18 column using acetonitrile: Distilled water (40: 60, v/v; flow rate – 1.0 mL/minute) and the PDA detector (247 nm). The method was validated as per the norms of the International
Conference on Harmonisation (ICH) guidelines and applied to study the pharmacokinetics of an oil‑based Ayurvedic preparation, in terms of bioavailable psoralen. Results: The HPLC method showed a linear detector response from 20.0 to 5000.0 ng/mL (r2=0.9998) for psoralen. The content of psoralen in P. corylifolia and its marketed formulations was determined, which showed remarkable variations as per the nature and complexity of the formulation. The absorption and elimination profile of psoralen, from an oil‑based Ayurvedic preparation, was developed on its topical application in rabbits. Psoralen was detected in the plasma 0.25 hours post application of
Bakuchi Taila with 0.46% bioavailability. Conclusion: The method was found to be sensitive, accurate and reproducible. Therefore,
it can be recommended for marker‑based standardisation and quality assurance of P. corylifolia and its formulations. It can also be applied to study the pharmacokinetic profile of the traditional preparations of P. corylifolia.
Key words: Formulations, Psoralea corylifolia, psoralen, pharmacokinetics, RP‑HPLC‑DAD

Full Text:



Khushboo PS, Jadhav VM, Kadam VJ, Sathe NS. Psoralea corylifolia

Linn.‑”Kushtanashini”. Pharmacogn Rev 2010;4:69‑76.

Uikey SK, Yadav AS, Sharma AK, Rai AK, Raghuwanshi DK,

Badkhane Y. The Botany, Chemistry, Pharmacological and

Therapeutic Application of Psoralea corylifolia L. – A Review. Int J

Phytomed 2010;2:100‑7.

Feng L, Wang L, Jiang X. Pharmacokinetics, Tissue Distribution

and Excretion of Coumarin Components from Psoralea corylifolia L.

in Rats. Arch Pharmacal Res 2010;33:225‑30.

Liu R, Li A, Sun A, Kong L. Preparative isolation and purification

of psoralen and isopsoralen from Psoralea corylifolia by high‑speed

counter‑current chromatography. J Chromatogr A 2004;1057:225‑8.

Shailajan S, Menon S, Singh A, Mhatre M, Sayed N. A Validated

RP‑HPLC method for quantitation of trigonelline from herbal

formulations containing Trigonella foenum‑graecum (L.) seeds.

Pharm Met 2011;2:157‑60.

Shailajan S, Singh A, Tiwari B. Quality Control and Standardization

of an Ayurvedic Taila formulation. Int J Biomed Res Anal


Champanerkar PA, Vaidya V, Shailajan S, Menon S. A sensitive,

rapid and validated liquid chromatography‑tandem mass

spectrometry (LC‑MS‑MS) method for determination of mimosine

in Mimosa pudica Linn. Nat Sci 2010;2:713‑7.

Shailajan S, Menon SN, Singh A. Quantitative analysis of piperine

from Ayurvedic polyherbal formulation using Reverse Phase

High Performance Liquid Chromatography. Int J Pharma Bio Sci


Lin CF, Huang Yl, Chien MY, Sheu SJ, Chen CC. Analysis

of Bakuchiol, Psoralen and Angelicin in Crude Drugs and

Commercial Concentrated Products of Fructus Psoraleae. J Food

Drug Anal 2007;15:433‑7.

Dong NT, Bae K, Kim YH, Hwang GS, Heo OS, Kim SE, et al.

Quantitative Determination of Psoralen and Angelicin from Some

Medicinal Herbs by High Performance Liquid Chromatography.

Arch Pharmacal Res 2003;26:516‑20.

Novikova IY, Tulaganov AA. Using HPLC for the quality control of

psoralen and related preparations. Pharm Chem J 2004;38:279‑81.

International Conference on Harmonization (ICH). Validation of

Analytical Procedures: Methodology. Q2 (R1). ICH harmonized

tripartite guideline. 1998.

Organization of Economic Co‑operation and Development

(OECD). Guidelines for Testing of Chemicals. No. 404. Acute

Dermal Irritation/Corrosion, Paris, France, 2004.

Draize JH, Woodard G, Calvery HO. Methods for the study

of irritation and toxicity of substances applied topically to the

skin and mucous membranes. J Pharmacol Exp Ther 1944;82:


Food and Drug Administration (FDA) of the United States.

Guidance for industry, Bioanalytical Method Validation, U.S.

Department of Health and Human services, Centre for Drug

Evaluation and Research (CDER) and Center for Veterinary

Medicine (CVM), 2001.

Bansal S, DeStefano A. Key Elements of Bioanalytical Method

Validation for Small Molecules. AAPS J 2007;9:E109‑14.

Ali J, Akhtar N, Sultana Y, Baboota S, Ahmad S. Thin‑Layer

Chromatographic analysis of psoralen in babchi (Psoralea corylifolia)

Oil. Acta Chromatogr 2008;20:277‑82.



  • There are currently no refbacks.