Acta Scientific Pharmaceutical Sciences (ASPS)(ISSN: 2581-5423)

Research Article Volume 4 Issue 2

Development and Validation of Stability Indicating Method for Simultaneous Estimation of Ilaprazole and Levosulpiride in Bulk and Capsules Using Design of Experiment Approach

Margi M Shah, Nishith H Teraiya and Archita J Patel*

Department of Pharmaceutical Chemistry, Kadi Sarva Vishwavidyalaya, Gandhinagar, Gujarat, India

*Corresponding Author: Archita J Patel, Department of Pharmaceutical Chemistry, Kadi Sarva Vishwavidyalaya, Gandhinagar, Gujarat, India.

Received: December 26, 2019; Published: January 08, 2019

×

Abstract

  A stability indicating High Performance Thin Layer Chromatography (HPTLC) was developed for the simultaneous estimation of Levosulpiride and Ilaprazole in bulk and capsule dosage form. The chromatographic conditions were optimized using Design of Experiment (DoE); where in the critical factors for separation of both drugs were identified using Taguchi design. Further, optimization was done using Central Composite design and it was then subjected to forced degradation study. The separation was achieved using mobile phase Toluene: Ethyl acetate: Methanol: Tri ethyl amine (TEA) (4.52: 2.5: 2.02: 0.2% v/v/v/v) with Rf values of 0.46 and 0.71 for Levosulpiride and Ilaprazole respectively. Linearity was observed in the concentration range of 3750-22500 ng/band for Levosulpiride and 500-3000 ng/band for Ilaprazole. Developed method was validated according to ICH guidelines. The developed method can be used for separation and simultaneous estimation of aforesaid drugs in capsule dosage form as well as in presence of degradation products.

Keywords:Central Composite Design; Levosulpiride; Ilaprazole; HPTLC; Stability Indicating

×

References

  1. http://www.drugs.com/international/levosulpiride.html
  2. http://www.drugs.com/international/ilaprazole.html
  3. Tripathi KD. “Essential medical pharmacology”. 6th edn, Jaypee brothers medical publishers (P) Ltd (2008): 647-648.
  4. Goyal RK. Elements of Pharmacology, 20th edn, B.S.Shah Prakashan, Ahmadabad (2011): 213-217.
  5. Devu D., et al. “Development and validation of Ilaprazole in bulk and pharmaceutical dosage form by UV spectroscopic method”. International Journal of Advances in Pharmaceutical Analysis 4.4 (2004): 130-133.
  6. Zhou G., et al. “An improved LCMS/MS method for quantitative determination of Ilaprazole and its metabolites in human plasma and its application to a pharmacokinetic study”. Acta Pharmacologica Sinica 39.9 (2009): 1330-1336.
  7. Satheesh B., et al. “Simultaneous determination of Ilaprazole and its related compounds in pharmaceutical dosage forms by UPLC”. Journal of Liquid Chromatography and Related Technologies 36.20 (2013): 2968-2981.
  8. Shelkea PG., et al. “Validated Stability-indicating assay method for determination of Ilaprazole in bulk drug and tablets by high performance liquid chromatography”. Eurasian Journal of Analytical Chemistry 10.1 (2014): 1-9. 
  9. Manjunath S and Chouhan. “Spectrophotometric estimation of Levosulpiride in bulk drug and formulations”. International Journal of Pharmacy and Pharmaceutical Sciences 3 (2011): 135-137.
  10. Jin ES., et al. “Development of HPLC mehtod for the determination of Levosulpiride in human plasma”. Journal of Pharmaceutical and Biomedical Analysis 35.4 (2004): 929-930. 
  11. Phapale PB., et al. “Liquid chromatography-Tandem mass spectrometry quantification of levosulpiride in human plasma and its appilication to bioequivalence study”. Journal of Chromatography B 878.24 (2010): 2280-2285.
  12. Trivedi K., et al. “Analytical Method Development and validation for simultaneous estimation of Ilaprazole and Levosulpiride in capsule”. American Journal of PharmTech Research 6.3 (2016): 416-426.
  13. Wass JA. “First steps in experimental Design-The screening experiment”. Journal of Validation Technology (2010): 46-53. 
  14. International Conference of Harmonization (ICH), Validation of Analytical Procedures: Text and Methodology, Q2A (R1), Geneva 62 (2005). 
  15. Bakshi M and Singh S. “Development of validated stability-indicating assay methods-critical review”. Journal of Pharmaceutical and Biomedical Analysis 28 (2002): 1011-1040.
  16. International Conference of Harmonization (ICH), Stability Testing of New Drug Substances and Products in International Conference on Harmonisation, IFPMA, Geneva (2003).
  17. Rakic T., et al. “Comparison of Full Factorial Design, Central Composite Design, and Box-Behnken Design in chromatographic method development for the determination of Fluconazole and its impurities”. Analytical Letters 47.8 (2014): 1334-1347.
×

Citation

Citation: Archita J Patel., et al. “Development and Validation of Stability Indicating Method for Simultaneous Estimation of Ilaprazole and Levosulpiride in Bulk and Capsules Using Design of Experiment Approach". Acta Scientific Pharmaceutical Sciences 4.2 (2020): 01-09.



Member In



News and Events


  • Certification for Review
    Acta Scientific certifies the Editors/reviewers for their review done towards the assigned articles of the respective journals.
  • Submission Timeline for March Issue
    The last date for submission of articles for regular Issues is March 15, 2020.
  • Publication Certificate
    Authors will be issued a "Publication Certificate" as a mark of appreciation for publishing their work.
  • Best Article of the Issue
    The Editors will elect one Best Article after each issue release. The authors of this article will be provided with a certificate of “Best Article of the Issue”.
  • Welcoming Article Submission
    Acta Scientific delightfully welcomes active researchers for submission of articles towards the upcoming issue of respective journals.
  • Contact US