Development and Validation of New RP-HPLC Method for Estimation of Pramipexole Dihydrochloride in Bulk and Pharmaceutical Formulation

Year 2022, Volume: 5 Issue: 1, 1 - 10, 28.04.2022

Moein Amel , Leyla Beba Pojarani , E. Vildan Burgaz , Ömer Türkmen

https://doi.org/10.54994/emujpharmsci.1031832

Abstract

A novel high-performance liquid chromatographic assay method was developed and validated for the quantitative determination of the anti-Parkinson agent pramipexole dihydrochloride monohydrate in bulk and its tablet dosage form. In this perspective, the chromatographic separation was accomplished on Eclipse XDB-12 C18 (150 mm x 4.6 mm, 5 μm particle size) column using UV detection at 263 nm. The mobile phase consisted of distilled water: acetonitrile (10: 90 v/v), run at a flow rate of 1.0 mL/min with isocratic elution. The method was validated in accordance with ICH guidelines by evaluating the system suitability, linearity, limits of detection (LOD) and quantitation (LOQ), precision, accuracy, specificity, selectivity and short-term stability. Our findings revealed that retention time for pramipexole dihydrochloride was found to be 5.2 minutes. The linearity range was established between 6.25-225.0 μg/mL with a mean recovery of 101.26 % ± 0.56. The limits of detection and quantification were determined to be 4.18 μg/mL and 12.66 μg/mL, respectively, indicating that the method is very sensitive. Intra and inter-day precision were within acceptable limits (RSD<2, n=6) and the typical excipients included in the pharmaceutical product did not interfere with the selectivity of the method. The proposed method was found to be simple, specific, accurate, precise and could be applied to the quantitative analysis of pramipexole dihydrochloride monohydrate in a bulk and in a its tablet dosage form.

Keywords

HPLC method development, pramipexole dihydrochloride, recovery, ICH.

References

• Benbir G, Guilleminault C (2006). Pramipexole: New use for an old drug - The potential use of pramipexole in the treatment of restless legs syndrome. Neuropsychiatr Dis Treat 2(4): 393–405.
• Deleu D, Northway MG, Hanssens Y (2002). Clinical pharmacokinetic and pharmacodynamic properties of drugs used in the treatment of Parkinson’s disease. Clin Pharmacokinet 41(4): 261–309.
• Dey S, Pradhan PK, Upadhayay UM, Desai K, Niranjani D (2012). Method Development and Validation of Pramipexole by UV Spectrophotometric Method. J Nat Sci 5(10): 5052–5054.
• Dooley M, Markham A (1998). Pramipexole. A review of its use in the management of early and advanced Parkinson’s disease. Drugs and Aging 12(6): 495–514.
• Goldenberg MM (2008). Medical management of Parkinson’s disease. P and T 33(10).
• Gurupadayya BM, Vishwajith V, Srujana N (2009). Spectrophotometric Methods for the Estimation of Pramipexole Dihydrochloride in Pharmaceutical Formulations. WJC 4(2): 157–160.
• ICH (2005). ICH Topic Q2 (R1) Validation of Analytical Procedures : Text and Methodology. International Conference on Harmonization, 1994 (November 1996), 17.
• Lipford MC, Silber MH (2012). Long-term use of pramipexole in the management of restless legs syndrome. Sleep Med 13(10): 1280–1285.
• MacKie S, Winkelman JW (2015). Long-Term Treatment of Restless Legs Syndrome (RLS): An Approach to Management of Worsening Symptoms, Loss of Efficacy, and Augmentation. CNS Drugs 29(5): 351–357.
• Muthu S, Uma Maheswari J, Srinivasan S, Isac Paulraj E. (2013). Spectroscopic studies, potential energy surface and molecular orbital calculations of pramipexole. Spectrochimica Acta - Part A: Molecular and Biomolecular Spectroscopy 115: 64–73.
• Panchal JG, Patel RV, Menon SK (2011). Development and validation of GC/MS method for determination of pramipexole in rat plasma. Biomed Chromatogr 25(4): 524–530.
• Panditrao VM, Sarkate AP, Sangshetti JN, Wakte PS, Shinde DB (2011). Stability-indicating HPLC determination of pramipexole dihydrochloride in bulk drug and pharmaceutical dosage form. J Braz Chem Soc 22(7): 1253–1258.
• Pathare DB, Jadhav AS, Shingare MS (2006). Validated chiral liquid chromatographic method for the enantiomeric separation of Pramipexole dihydrochloride monohydrate. J Pharm Biomed 41(4): 1152–1156.
• Pawar SM, Khatal LD, Gabhe SY, Dhaneshwar SR (2013). Establishment of inherent stability of pramipexole and development of validated stability indicating LC-UV and LC-MS method. J Pharm Anal 3(2): 109–117.
• Rambhade S, Chakraborty A, Patil U, Rambhade A (2010). Journal of Chemical and Pharmaceutical Research preparations. J Chem Pharm Res 2(6): 7–25.
• Sevim S, Erk N (2015). Validation of high performance liquid chromatographic and spectrophotometric methods for the determination of the antiparkinson agent pramipexole dihydrochloride monohydrate in pharmaceutical products. Braz J Pharm Sci 51(4): 879–891.
• Silber MH, Ehrenberg BL, Allen RP, Buchfuhrer MJ, Earley CJ, Hening WA, Rye DB (2004). An algorithm for the management of restless legs syndrome. MACPAJ 79(7): 916–922.
• Thangabalan B, Vamsi Krishna M, Raviteja NVR, Hajera Begum SK, Manohar Babu S, Vijayaraj Kumar P (2011). Spectrophotometric methods for the determination of Pramipexole Dihydrochloride in pure and in pharmaceutical formulations. Int J Pharm Pharm Sci 3(SUPPL. 3): 84–85.
• Venkata Rajesh N, DeepaRamani Durraivel. (2013). RP-HPLC method for the determination pramipexole dihydrochloride in tablet dosage form. Int J Pharm Clin Res 5(1): 17–22.