Stability Indicating Method Development and Validation for Assay of Omeprazole Sodium for Injection by a Rapid RP-HPLC

Authors

  • Aishwarya Dande Department of Pharmaceutical Analysis, G. Pulla Reddy College of Pharmacy (Ou), Mehidipatnam, Hyderabad, Telangana.
  • Gummadi Rishitha Reddy Department of Pharmaceutical Analysis, G. Pulla Reddy College of Pharmacy (Ou), Mehidipatnam, Hyderabad, Telangana
  • Gaddam Saithya Saithya Department of Pharmaceutical Analysis, G. Pulla Reddy College of Pharmacy (Ou), Mehidipatnam, Hyderabad, Telangana.

DOI:

https://doi.org/10.22270/ajprd.v9i2.943

Keywords:

Omeprazole, Omeprazole sodium for injection, HPLC.

Abstract

Omeprazole,13 a member of proton pump inhibitor, used for the treatment of peptic ulcers, it supresses gastric acid secretion by inhibiting H+/K+ ATPase. A new fundamental, rapid and sensitive HPLC method was developed for the assay of Omeprazole sodium for injection. It was validated according to ICH and FDA guidelines 2. The HPLC analysis was performed on Dionex ultimate 3000 system equipped with C-18 (150cm*4.6mm) 5µ column, with a mixture of ammonium acetate and acetonitrile buffer in the ratio 65:35 v/v as the mobile phase at the wavelength (λ) 305nm. The total run time was 8 minutes. The calibration curve was linear for 50-150% range of the analytical concentration of 40mg/ml, r2 was found to be 0.9998. The precision was calculated and % RSD was 0.1 % and the recovery of omeprazole was within the range of  98-102%. Validation parameters like robustness, solution stability studies, specificity and forced degradation studies were performed and found to be within acceptance limits. As compared to other methods, this method was found to be more accurate, linear, precise and specific, with short run time. All the results were acceptable and confirmed that the method is suitable for its intended use in routine quality control analysis.

 

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Author Biographies

Aishwarya Dande, Department of Pharmaceutical Analysis, G. Pulla Reddy College of Pharmacy (Ou), Mehidipatnam, Hyderabad, Telangana.

Department of Pharmaceutical Analysis, G. Pulla Reddy College of Pharmacy (Ou), Mehidipatnam, Hyderabad, Telangana.

Gummadi Rishitha Reddy, Department of Pharmaceutical Analysis, G. Pulla Reddy College of Pharmacy (Ou), Mehidipatnam, Hyderabad, Telangana

Department of Pharmaceutical Analysis, G. Pulla Reddy College of Pharmacy (Ou), Mehidipatnam, Hyderabad, Telangana

Gaddam Saithya Saithya, Department of Pharmaceutical Analysis, G. Pulla Reddy College of Pharmacy (Ou), Mehidipatnam, Hyderabad, Telangana.

Department of Pharmaceutical Analysis, G. Pulla Reddy College of Pharmacy (Ou), Mehidipatnam, Hyderabad, Telangana.

References

1. Roberto Cirilli 1, Rosella Ferretti, Bruno Gallinella, Emiliana De Santis, Leo Zanitti, Francesco La Torre. High-performance liquid chromatography enantioseparation of proton pump inhibitors using the immobilized amylose-based Chiral peak IA chiral stationary phase in normal-phase, polar organic and reversed-phase conditions. J Chromatogr A. 2008; 1177(1):105–13.
2. ICH Harmonised Tripartite Guideline.Validation of analytical procedures:text and methodology, Q2(R1),USA,2005:1-13.
3. ICH Guideline:Validation of analytical procedures: text and methodology, in Proceedings of International Conference on Harmonization,Q2(R1), Geneva, Switzerland, 2005.
4. Harshal, K.T. and Mukesh, C.P. Development and Validation of a precise single HPLC Method for Determination of Omeprazole and its related compound in pharmaceutical formulation. Indian journal of pharmaceutical sciences. 1997; 59(3):124-127.
5. Martindale.The Complete Drug Reference, Pharmaceutical Press, London, UK, 2005; 34:1536-5050.
6. Neil MJO, Ed., The Merk Index- An Encyclopedia of Chemicals, Drugs and Biological, Merck Research Laboratories.2006; 14.
7. L.L. Brunton, J.S. Lazo, and K. L. Parker. Goodman & Gilman's the pharmacological basis of therapeutics. McGraw-Hill Professional. 2005;11: 969.
8. P. S. Bonato and F. O. Paias, J. Braz. Chem. Soc.2004; 15(2):318.
9. S. Vyas, A. Patel, K. D. Ladva, H. S. Joshi, and A. H. Bapodra, J. Pharm. Bioallied. Sci.2011; 3(2):310.
10. Kalakonda Sri Nataraj1, Mohammad Badrud Duza1, Kalyani Pragallapati1, Dussa Kiran Kumar. Development and validation of RP-HPLC method for the estimation of omeprazole in bulk and capsule dosage forms. International current pharmaceutical journal.2012; 1(11):366-369
11. Fabio S. Murakami, Ariane P. Cruz, Rafael N. pereira. Development and Validation of a RP‐HPLC Method to Quantify Omeprazole in Delayed Release Tablets. Journal of liquid chromatography and related technologies. 2007; 30(1):113-121.

Published

2021-04-15

How to Cite

Dande, A., Reddy, G. R., & Saithya, G. S. (2021). Stability Indicating Method Development and Validation for Assay of Omeprazole Sodium for Injection by a Rapid RP-HPLC. Asian Journal of Pharmaceutical Research and Development, 9(2), 18–26. https://doi.org/10.22270/ajprd.v9i2.943