DEVELOPMENT AND VALIDATION OF UV SPECTROPHOTOMETRIC METHOD AND RP-HPLC METHOD FOR ESTIMATION OF CAPECITABINE IN BULK AND TABLET DOSAGE FORMS


K. Pallavi, P. Srinivasa Babu, G. Kishore Babu

Abstract


Objective: The objective of the present work is to develop and validate a novel, specific, precise and reliable method for estimation of Capecitabine in bulk and pharmaceutical dosage form using UV-visible spectroscopy and RP-HPLC method.

Methods: UV-visible spectrophotometric determination was performed with Elico double beam SL 210 UV-visible spectrophotometer having deuterium lamp at λmax 304 nm using water as a medium. Linearity was noted over a concentration range of 2-20 µg/ml with a correlation coefficient of 0.99. HPLC analysis was performed using Eclipse XDB C18 column with 5 µm particle size having dimensions 4.6 X 250 mm column, Agilent 1260 infinity DAD detector, 1260 infinity quaternary pump using Ezchrome software at a flow rate of 1 ml/min and a run time pressure of 2140 psi. Methanol: acetonitrile: water in the ratio 30: 30: 40 was used as mobile phase and the effluents were analyzed at 304 nm. Both the proposed methods were validated for various parameters like linearity, precision, accuracy, robustness, ruggedness, selectivity, detection, quantification limits, formulation analysis as per International Conference on Harmonization (ICH) guidelines.

Results: Linearity for UV and HPLC method was noted over a concentration range of 2-100 µg/ml with a correlation coefficient of 0.99. The retention time was considered to be 4.60 min. The % RSD for interday and intraday precision studies and recovery analysis of both UV and HPLC methods was found to be less than 1% which is less than the official RSD limit (2%). Recovery analysis performed using marketed formulation capeguard was considered to be greater than 99% for both the methods.

Conclusion: Both the methods developed were validated according to the ICH guidelines. Hence it was evident that the developed methods were novel, sensitive, precise and reliable for estimation of Capecitabine in bulk and were successfully applied for estimation of pharmaceutical dosage forms.

Keywords: Capecitabine, UV-visible spectroscopic method, HPLC method, Validation

 


| PDF | HTML |

References


Louis S Goodman, Joel G Hardman, Lee E Limbird, Alfred Goodman Gilman. Goodman and Gilman's the pharmacological basis of therapeutics. 10th edition. New York; 2001. p. 874-86.

Indian Pharmacopoeia Commission. Indian Pharmacopoeia. 6th edition. Ghaziabad; 2010. p. 972-4.

Beckett AH, Stenlake JB. Practical pharmaceutical chemistry: Vol. II. CBS Publisher and Distributors, New Delhi; 1986. p. 13-7.

Acy F, Charles L, Armstrong Lora, Goldman P, Mortan Lance, L Leonard. Lexi-Comp’s Drug Information Handbook. 12th Edition. Lexi-Comp inc; 2004.

R Gieschke, HU Burger, B Reigner, KS Blesch, JL Steimer. Population pharmacokinetics and concentration-effect relationships of capecitabine metabolites in colorectal cancer patients. J Clin Pharmacol 2003;55:252-63.

Beckett AH, Stenlake JB, Practical Pharmaceutical Chemistry. Vol. II. CBS Publisher and Distributors, New Delhi; 1986. p. 13-7.

Sharma BK. Instrumental methods of chemical analysis. 7th Ed. Goel Publishing House, Meerut; 2000. p. 1-2.

Xeloda (capecitabine) dosing, indications, interactions, adverse effects, and more. Medscape Reference. WebMD; 2014.

The United States of pharmacopeia. Vol 2. The United States of Pharmacopeia-National Formulary; 2008. p. 1620-2.

American Society of Health-System Pharmacists. ASHP guidelines on handling hazardous drugs. Am J Health-Syst Pharm 2006;63:1172-93.

M Naveen kumar, M Krishna chaitanya. Validated UV spectrophotometric method for quantitative analysis of capecitabine in pharmaceutical dosage form. J Chem Pharm Sci 2013;6:231-7.

B Reigner, J Verweij, I Dirix, J Cassidy, C Twelves, D Allman, et al. Identification, separation, isolation, and characterization of impurities present in capecitabine active pharmaceutical ingredient. Clin Cancer Res 1998;4:941-50.

Karnaker Reddy Y, Sravan Kumar S, Ravindra Reddy Y. Estimation of capcetabine drug present in tablets by RP-HPLC method. J Pharm Res 2011;4:256-8.

Narendra Devanaboyina, Y Sai kishore, P Pushpalatha, N Mamatha, P Venkatesh. Development and validation of new RP HPLC method for analysis of capecitabine in pharmaceutical dosage form. Int J Sci Inventions Today 2013;2:21-30.

Sumanta mondal, Reddy narendra, Debjit ghosh, Seru ganapaty. Development and validation of RP-HPLC and UV spectrophotometric methods for the quantification of capecitabine. Int J Pharm Pharm Sci 2016;8:1-9.

P Gangi Reddy. Simultaneous determination of capecitabine and its metabolites by HPLC and mass spectrometry for preclinical and clinical studies. J Chrom 2005;826:232-7.

Validation of analytical procedures: Text and methodology. International Conference on Harmonization (ICH) Q2 (R1) guideline. Geneva, Switzerland; 2005.

Makula A, Anjum F, Tangadpally R, Kondepudi RK. Analytical method development and validation of capecitabine in bulk by RP-HPLC method. Int Res J Pharm 2012;3:177-80.

Rao MS, Ramesh G. Development and validation of a simple and specific UV spectrophotometric method for capecitabine assay in active pharmaceutical ingredients (API) and in its dosage forms. Int J Pharm Pharm Res 2015;2:152-60.




About this article

Title

DEVELOPMENT AND VALIDATION OF UV SPECTROPHOTOMETRIC METHOD AND RP-HPLC METHOD FOR ESTIMATION OF CAPECITABINE IN BULK AND TABLET DOSAGE FORMS

Date

19-06-2016

Additional Links

Manuscript Submission

Journal

International Journal of Applied Pharmaceutics
Vol 8, Issue 3, 2016 Page: 24-29

Online ISSN

0975-7058

Statistics

87 Views | 92 Downloads

Authors & Affiliations

K. Pallavi
Department of Pharmaceutics, Vignan Pharmacy College, Vadlamudi, Guntur (dt.), ap, 522213
India

P. Srinivasa Babu

G. Kishore Babu


Refbacks

  • There are currently no refbacks.