DEVELOPMENT AND VALIDATION OF STABILITY INDICATING REVERSE PHASE HIGH‑PERFORMANCE LIQUID CHROMATOGRAPHIC METHOD FOR THE ESTIMATION OF PIRIBEDIL IN BULK DRUG

  • Kandala Bhaskara Veera Rohith AU college of pharmaceutical Sciences, Andhra University
  • Venkata Ramana G
  • Venkata Ramana G
  • Madhavi Latha N
  • Madhavi Latha N
  • Supriya P
  • Supriya P
  • Harini U
  • Harini U
  • Pawar Akm
  • Pawar Akm

Abstract

ABSTRACT
Objective: A simple, precise, fast, economic, accurate, robust, and stability indicating isocratic reverse phase high-performance liquid chromatographic
method was developed for the analysis of Piribedil.
Method: The chromatographic conditions were standardized using Unisol C-18 (4.6 × 150 mm × 3.0 μ) column with UV detection at 244 nm, and the
mobile phase composed of methanol:acetate buffer-pH 5.0 (85:15, v/v).
Results: The retention time of Piribedil was found to be 3.4 minutes. The calibration curve was linear with correlation coefficient of 0.999 over a
concentration range of 20-100 μg/ml with linear regression equationy=74,69,224.37x−39,46,924.90. The limit of detection and limit of quantitation
were found to be 0.04 and 0.4 μg/ml, respectively.
Conclusion: The proposed method has been validated according to the ICH guidelines. Piribedil was subjected to stress conditions including
acidic, alkaline, oxidation, photolysis, and thermal degradation. Piribedil is more sensitive to photolytic stress. There are no interfering peaks from
degradation products at analyte retention time, and thus the method is specific for the estimation of Piribedil in the presence of degradation products.
Thus, the proposed method can be successfully applied in the routine quality control and stability samples of Piribedil in bulk drug.
Keywords: Piribedil, Validation, Stability indicating, Reverse phase high-performance liquid chromatographic.

References

REFERENCES
1. Wikipedia. Piribedil. 2015. Available from: https://www.en.wikipedia.
org/wiki/Piribedil. [Last cited on 2015 Feb 01].
2. Ailments D. Drugs N. Piribedil - Find Alternatives, Check Prices only
at 1mg.com. 1mg.com. 2015. Available from: https://www.1mg.com/
generics/piribedil-210524. [Last cited on 2015 Feb 18].
3. WebMD. Parkinson’s Disease Health Center. 2015. Available from: http://
www.webmd.com/parkinsons-disease/. [Last cited on 2015 Feb 18].
4. Altiokka G, Can N, Aboul-Enein H. Determination of piribedil in
human serum, Urine and pharmaceutical dosage form by LC-DAD.
Chroma 2008;67(11-12):905-10.
5. Sarati S, Guiso G, Spinelli R, Caccia S. Determination of piribedil
and its basic metabolites in plasma by high-performance liquid
345
Asian J Pharm Clin Res, Vol 9, Issue 1, 2016, 342-346
Rohith et al.
chromatography. J Chromatogr B Biomed Sci Appl 1991;563(2):323 32.
6. International Conference on Harmonization (ICH) of Technical
Requirements for the Registration of Pharmaceuticals for Human Use.
Stability Testing of New Drug Substances and Products, Q1A (R2).
Geneva: International Conference on Harmonization; 2003.
7. Ebi.ac.uk. Compound Report Card. 2015. Available from: https://www.
ebi.ac.uk/chembl/compound/inspect/CHEMBL1371770. [Last cited on
2015 Mar 08].
8. International Conference on Harmonization (ICH) of Technical
Requirements for the Registration of Pharmaceuticals for Human Use.
Validation of Analytical Procedures: Definitions and Terminology, Q2A.
Geneva: International Conference on Harmonization; 1996.
9. International Conference on Harmonization (ICH) of Technical
Requirements for the Registration of Pharmaceuticals for Human Use.
Validation of Analytical Procedures: Methodology, Q2B. Geneva:
International Conference on Harmonization; 1996.
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How to Cite
Rohith, K. B. V., V. Ramana G, V. Ramana G, M. Latha N, M. Latha N, S. P, S. P, H. U, H. U, P. Akm, and P. Akm. “DEVELOPMENT AND VALIDATION OF STABILITY INDICATING REVERSE PHASE HIGH‑PERFORMANCE LIQUID CHROMATOGRAPHIC METHOD FOR THE ESTIMATION OF PIRIBEDIL IN BULK DRUG”. Asian Journal of Pharmaceutical and Clinical Research, Vol. 9, no. 1, Jan. 2016, pp. 342-6, https://innovareacademics.in/journals/index.php/ajpcr/article/view/9709.
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Original Article(s)