METHOD DEVELOPMENT AND VALIDATION OF STABILITY INDICATING UPLC ASSAY METHOD FOR NIFEDIPINE

  • Shalini Bhardwaj
  • M. K. Gupta
  • V. Bhalla
DOI https://doi.org/10.22270/ijdra.v3i4.174

Abstract

A simple and rapid stability indicating, ultra performance liquid chromatographic (UPLC) method was developed and validated for the determination of Nifedipine. The quantitative determination of Nifedipine drug was performed on a Sunniest C-18-HT, 2m, (50 2.1nm) column with gradient elution. For UPLC method, UV detection was made at 335nm. During method validation, parameters such as precision, linearity, stability, robustness and specificity were evaluated, which remained within acceptable limits. Forced degradation studies of Nifedipine were studied under acidic and alkaline stress conditions. Mild degradation of the drug substance was observed during acidic hydrolysis and no degradation was observed during basic hydrolysis.

Keywords: Nifedipine, UPLC, Stability indicating assay, Validation.

Downloads

Download data is not yet available.

References

1. Tripati KD. Essentials of Medical Pharmacology. 6th ed. Jaypee Brothers Medical Publishers (P) Ltd.; 2008.p. 528-31.
2. Finkel, Richard, Clark, Michelle A, Cubeddu, Luigi X. Pharmacology. 4th ed. Lippincott's Illustrated Reviews; 2015.p. 212.
3. Nifedipine, Drug Bank [Internet] Drug Bank; 2005 June 13 [cited 2015 Nov 02]. Available from: www.drugbank.ca/drugs/db01115
4. Nifedipine, MedlinePlus [Internet] U.S. National Library of Medicine; 2015 April 15 [cited 2015 Nov 13]. Available from:
www.nlm.nih.gov/medlineplus/druginfo/meds/a684028.html
5. Shelke OS, Sable KS, Neharkar VS and Mathdevru BV. Development and validation of a UV spectrophotometric method for the simultaneous determination of nifedipine and atenolol in combined dosage form. IRJP. 2012; 3(4).
6. Parida P, Mishra SC and Tripathy SP. Simple spectrophotometric method validation of Nifedipine Solid Dosage Form. Indo American Journal of Pharmaceutical Research. 2014; 4(05).
7. Milenović DM, Lazić ML, Veljković VB, and Todorović ZB. Validation of an HPLC method for analysis of Nifedipine residues on Stainless-Steel surfaces in the manufacture of Pharmaceuticals. Acta Chromatographica. 2008; (20)2:183-94.
8. AL-Jammal MKH, Al Ayoub Y and Assi KH. Development and validation of Micro Emulsion high performance liquid chromatography(MELC) Method for the determination of Nifedipine in Pharmaceutical Preparation. Pharm. Anal. Acta. 2015; 6(3): 1-5.
9. Uday YA, Patel SK, Kumar D and Sandip AB. Estimation of nifedipine by reverse phase high performance liquid chromatography tablet dosage form. International Journal of Pharmacy & Life Sciences. 2011 Mar; 2(3).
10. Sankaa K, Gullapellia R, Patila N, Padmanabha Rao AB and Divana PV. Development and validation of RP-HPLC method for Nifedipine and its application for a novel proniosomal formulation analysis and dissolution study. Der Pharma Chemica. 2014; 6(1): 279-89.
11. Asirvatham S, Kamble SN. Reversed-Phase Liquid Chromatographic method for simultaneous determination of Atenolol and Nifedipine in a Capsule formulation. World Journal of Pharmaceutical Research. 2014 Nov; 3(9): 1466-75.
12. Vidyadhara S, Sasidhar RLC, Kumar BP, Ramarao NT and Sriharita N. Method development and validation for simultaneous estimation of Atenolol and Nifedipine in Pharmaceutical dosage forms by RP-HPLC. Oriental Journal of Chemistry. 2012; 28(4):1691-6.
13. Zendelovska D, Simeska S, Sibinovska O, Kostova E, Miloˇsevska K, Jakovski K, et al. Development of an HPLC method for the determination of Nifedipine in human plasma by solid-phase extraction. Journal of Chromatography B. 2006; 839:85-8.
14. Bhardwaj S, Vandana A, Vijay B and Manish K. Gupta. Ultra Performance Liquid Chromatography: A Revolutionized LC Technique. International Journal of Drug Regulatory Affairs. 2014; 2(3):83-7.
15. Wren SAC, Tchelitcheff P. Use of ultra-performance liquid chromatography in pharmaceutical development. Journal of Chromatography A. 2006; 1119:140-6.
16. Novakova L, Matysova L and Solich P. Advantages of application of UPLC in pharmaceutical analysis. Talanta. 2006; 68:908-18.
17. International Conference on Harmonization (ICH), Stability testing of new drug substances and procedures, Proceedings of the International Conference on Harmonization. Geneva: ICH; 1993.
18. The United States Pharmacopoeia, United States Pharmacopoeia convention, MD. 2003; 26:1151-4.
Statistics
600 Views | 897 Downloads
How to Cite
Bhardwaj, S., M. K. Gupta, and V. Bhalla. “METHOD DEVELOPMENT AND VALIDATION OF STABILITY INDICATING UPLC ASSAY METHOD FOR NIFEDIPINE”. International Journal of Drug Regulatory Affairs, Vol. 3, no. 4, Feb. 2018, pp. 24-42, doi:10.22270/ijdra.v3i4.174.
Issue
Vol 3 No 4 (2015): VOLUME 3, ISSUE 4, 2015
Section
Research
Creative Commons License

This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.

The International Journal of Drug Regulatory affairs require a formal written transfer of copyright from the author(s) for each article published. We therefore ask you to complete and return this form, retaining a copy for your records. Your cooperation is essential and appreciated. Any delay will result in a delay in publication.

I/we have read and agree with the terms and conditions stated Page 2 of this agreement and I/we hereby confirm the transfer of all copyrights in and relating to the above-named manuscript, in all forms and media, now or hereafter known, to the International Journal of Drug Regulatory affairs, effective from the date stated below. I/we acknowledge that the IJDRA is relying on this agreement in publishing the above-named manuscript. However, this agreement will be null and void if the manuscript is not published in the IJDRA.

Download link for COPYRIGHT FORM