Asian Journal of Pharmaceutical Analysis

Open Access Open Access  Restricted Access Subscription Access
Open Access Open Access Open Access  Restricted Access Restricted Access Subscription Access

Development and Validation of a RP-HPLC Method for Estimation of Thalidomide in Solid Dosage form


Affiliations
1 College of Pharmacy, Shree Ganpati Institute of Technology, NH-24, Opp. Jindal Pipes Ltd, Ghaziabad, (U.P.), Indonesia
2 College of Pharmacy, Shree Ganpati Institute of Technology, NH-24, Opp. Jindal Pipes Ltd, Ghaziabad, (U.P.), India
3 School of Pharmacy, Galghotia University, Greater Noida, G B Nagar, (U. P.), India
     

   Subscribe/Renew Journal


A simple, rapid and precise isocratic reverse phase High Performance Liquid Chromatographic method has been developed for the determination of Thalidomide capsule. The separation was achieved with 150×4.6mm C18 column using mobile phase as Acetonitrile: Dimethyl Formamide : Water (60:10:30 v/v) at a flow rate of 1.0ml/min with UV detection at 297nm. The retention time of Thalidomide was found to be 2.17min. The linearity range of Thalidomide is 25mg to 200mg with coefficient of correlation 0.9986. The method is found to be accurate, precise and useful in quality control of dosage form.

Keywords

RP–HPLC, Thalidomide, Method Development and Validation
Subscription Login to verify subscription
User
Notifications
Font Size


  • Mellin GW, Katzenstoin M The Saga of Thalidomide- Neuropathy to Embryopathy, with Case Reports of Congenital Anomalies. New English Journal of Medicine. 267 (23); 1962: 1184-1193.

  • Czejka MJ anf Koch HP Determination of thalidomide and its major metabolites by high-performance liquid chromatography. Journal of Chromatography B: Biomedical Sciences and Applications. 413; 1987: 181–187

  • Youle M Clarbour J Farthing C Connolly M Hawkins D Staughton R and Gazzard B Treatment of resistant aphthous ulceration with thalidomide in patients positive for HIV antibody. British Medical Journal 432 (1); 1989: 298.

  • Gorin I Vilette B Gehanno P and Escande JP Thalidomide in hyperalgic pharyngeal ulceration of AIDS. Lancet 335 (8701); 1990: 1343.

  • Georghiou PR, Kemp RJ. HIV-associated esophageal ulcers treated with thalidomide. Medical Journal of Australia. 152; 1990:382-383.

  • Radeff B Kuffer R Samson J. Recurrent aphthous ulcer in patient infected with human immunodeficiency virus: successful treatment with thalidomide. Journal of American Acadamy of Dermatol. 23; 1990:523-525.

  • Li J Jaworsky MS and Stirling DI The determination of a potential impurity in Thalidomide drug substance and product by HPLC with indirect UV detection. Journal of Pharmaceutical and Bioedical Analysis. 31(1); 2003: 19-27.

  • Toraño JS Verbon A Guchelaa HJ Quantitative determination of thalidomide in human serum with high-performance liquid chromatography using protein precipitation with trichloroacetic acid and ultraviolet detection. Journal of Chromatography B: Biomedical Sciences and Applications. 734(2); 1999: 203-210.

  • Singh RM Shivraj Mathur SC Singh GN Sharma PK and Gupta SK Method development and its validation of Drug Thalidomide in API usinf RP-HPLC method. Journal of Indian Council of Chemist. 22(2); 2006: 25-27.

  • Singh S Singh UK Singh RM Singh GN Mathur SC Saini PK Yadav A Gupta V and Duggal D Development and validation of a RP-HPLC method for estimation of prulifloxacin in tablet dosage form. Indian Journal of Pharmaceutical Science. 73(5); 2011: 557.

  • Chen TL Vogelsang GB Petty BG Brundrett RB Noe DA Santos GW and Colvin OM Plasma pharmacokinetics and urinary excretion of thalidomide after oral dosing in healthy male volunteers.Drug Metabolism Disposition 17; 1989: 402-405

  • Shabir GA (2003) Validation of HPLC methods for pharmaceutical analysis: Understanding the differences and similarities between validation requirements of the U.S. Food and Drug Administration, the U.S. Pharmacopoeia and the International Conference on Harmonization. J Chromatogr A. 987; 57.

  • International Conference on Harmonisation, (1996) Guidance for Industry In: Q2B Validation on Analytical Procedures. Methodology Switzerland IFPMA, 1.


Abstract Views: 465

PDF Views: 2




  • Development and Validation of a RP-HPLC Method for Estimation of Thalidomide in Solid Dosage form

Abstract Views: 465  |  PDF Views: 2

Authors

Shiv Kumar Gupta
College of Pharmacy, Shree Ganpati Institute of Technology, NH-24, Opp. Jindal Pipes Ltd, Ghaziabad, (U.P.), Indonesia
Babita Kumar
College of Pharmacy, Shree Ganpati Institute of Technology, NH-24, Opp. Jindal Pipes Ltd, Ghaziabad, (U.P.), India
Pramod Kumar Sharma
School of Pharmacy, Galghotia University, Greater Noida, G B Nagar, (U. P.), India

Abstract


A simple, rapid and precise isocratic reverse phase High Performance Liquid Chromatographic method has been developed for the determination of Thalidomide capsule. The separation was achieved with 150×4.6mm C18 column using mobile phase as Acetonitrile: Dimethyl Formamide : Water (60:10:30 v/v) at a flow rate of 1.0ml/min with UV detection at 297nm. The retention time of Thalidomide was found to be 2.17min. The linearity range of Thalidomide is 25mg to 200mg with coefficient of correlation 0.9986. The method is found to be accurate, precise and useful in quality control of dosage form.

Keywords


RP–HPLC, Thalidomide, Method Development and Validation

References