Research Journal of Pharmacy and Technology

Open Access Open Access  Restricted Access Subscription Access
Open Access Open Access Open Access  Restricted Access Restricted Access Subscription Access

Development and Validation of Rp-hplc Method for the Determination of Ropinirole Hydrochloride in Bulk and Pharmaceutical Dosage Forms


Affiliations
1 Department of Pharmaceutical Analysis, GITAM Institute of Pharmacy, GITAM (Deemed to be University), Visakhapatnam - 530045, Andhra Pradesh, India
     

   Subscribe/Renew Journal


A simple, precise, rapid and accurate RP-HPLC method was developed for the estimation of Ropinirole hydrochloride in pure and pharmaceutical dosage forms. The method employed a Phenomenex C8 column (250 × 4.6mm, 5μm) and a mobile phase consisting of 0.1% orthophosphoric acid (pH 2.61) and methanol in the ratio of 50:50 v/v. The flow rate was optimized at 1.2mL/min and the effluents were monitored at 248 nm over a run time of 10.0 min. where the analyte showed the retention at 2.91±0.26 min. The detector response was linear in the concentration of 1-100μg/mL (y = 40236x – 10950). The limit of detection and limit of quantification were found to be 0.0007μg/mL and 0.0021μg/mL respectively. The method was validated as per ICH guidelines and was found to be sensitive, accurate, precise and robust while satisfying all the system suitability. The method was also tested for its stability indicating capability by performing the forced degradation studies and the drug was almost stable in all the exposed conditions with very minor degradations observed. The developed method was used for the assay of the drug in marketed tablets and the percentage assay was found to be 99.32±0.83 %w/w. The results of the study depict that the proposed RP-HPLC method is specific and sensitive for the routine analysis of Ropinirole hydrochloride in bulk drug and in its pharmaceutical dosage form.

Keywords

Ropinirole hydrochloride, RP-HPLC, Validation, Stability indicating, ICH.
Subscription Login to verify subscription
User
Notifications
Font Size


  • Yogita S, Nayana P, Nalawade RS, Pore YV, Kuchekar BS. Spectrophotometric estimation of Ropinirole hydrochloride in tablets. Indian Journal of Pharmaceutical Sciences. 2009; 71(1): 61-62.

  • Monali SS, Ajay LB, Vinit DP, Ajay SB, Vishnu PC, Bhanudas SK. Development and validation of area under curve and first derivative spectrophotometric methods for Ropinirole in tablet dosage form. Der Pharma Chemica. 2010; 2(3): 225-229.

  • Debra JT, Deborah V. Steady-state pharmacokinetic properties of a 24-hour prolonged-release formulation of Ropinirole: Results of two randomized studies in patients with parkinson's disease. Clinical Therapeutics. 2007; 29(12): 2654-2666.

  • Zeynep A. Highly sensitive and selective spectrophotometric and spectrofluorimetric methods for the determination of Ropinirole hydrochloride in tablets. Spectrochimica Acta Part A. 2008; 70(1): 69-78.

  • Raghubabu K, Jagannadharao V, Kalyanaramu B. Assay of Ropinirole hydrochloride in pharmaceutical preparations by visible spectrophotometry. Asian Journal of Pharmaceutical Analysis. 2012; 2(2): 41-45.

  • Srikanth I, Srilatha M, Ratna KP, Suresh PV. Novel method for the quantification of Ropinirole hydrochloride in pure API and its marketed formulations using 3-methyl-2-benzothiazolinone hydrazone hydrochloride and p-dimethylaminocinnamaldehyde as chromogenic reagents by spectrophotometry. Chemical Science Transactions. 2017; 6(4): 614-618.

  • Sreekanth N, Babu Rao CH, Mukkantu K. RP-HPLC method development and validation of Ropinirole hydrochloride in bulk and pharmaceutical dosage forms. International Journal of Pharmacy and Pharmaceutical Sciences. 2009; 1(1): 186-192.

  • Lata PK, Madhuri EC, Asha BT, Rabindra KN, Avinash DD, Punam SG. Validated RP-HPLC and spectrophotometric determination of Ropinirole hydrochloride in bulk and in pharmaceutical dosage form. Der Pharma Chemica. 2011; 3(6): 1-9.

  • Alivelu S, Sowmya M, Sasikala M, Kishore C. Development and validation of RP-HPLC method for the estimation of Ropinirole hydrochloride in tablet dosage forms. Journal of Chemical and Pharmaceutical Research. 2014; 6(3): 1178-1182.

  • Abhishek C, Sheikh M, Nitesh C, Puspendra K, Sanjar A, Surya P. Analytical methodology or authentication of Ropinirole using HPLC and FT-IR. International Journal of Drug Discovery and Research. 2015; 7(1): 234-239.

  • Sadashivaiah R, Rohith G, Sateesha Babu BK. Quantification of Ropinirole hydrochloride in API and tablets by novel stability indicating RP-HPLC method: Its validation and forced degradation studies. International Journal of Applied Pharmaceutics. 2019; 11(5): 317-323.

  • Hefnawy M, Abdulrhman Al-M, Mostafa M, Sabry A, Rizk M, Rasha Th. El-Eryan: Development of a monolithic HPLC-ECD method for the determination of Ropinirole HCl in mouse sera and dosage forms. British Journal of Pharmaceutical Research 2016; 13(3):1-11.

  • Coufal P, Stulik K, Claessens HA, Hardy MJ, Webb M. Separation and quantification of Ropinirole and some impurities using capillary liquid chromatography. Journal of Chromatography B: Biomedical Sciences and Applications. 1999; 732(2): 437-444.

  • Coufal P, Stulik K, Claessens HA, Hardy MJ, Webb M. Determination of the dissociation constants of Ropinirole and some impurities and their quantification using capillary zone electrophoresis. Journal of Chromatography B: Biomedical Sciences and Applications. 1998; 720(1-2): 197-204.

  • ICH Harmonized Tripartite Guideline; Validation of Analytical Procedures: Text and Methodology, Q2(R1); International conference on Harmonization, IFPMA, Geneva, Switzerland; 2005.

  • ICH Harmonized Tripartite Guideline; Stability Testing of New Drug Substances and New Drug Products Q1A (R2); International conference on Harmonization, IFPMA, Geneva, Switzerland; 2003.

  • ICH Harmonized Tripartite Guideline; Stability testing: Photo stability testing of new drug substances and products Q1B; International Conference on Harmonization, IFPMA, Geneva, Switzerland; 1996.


Abstract Views: 237

PDF Views: 0




  • Development and Validation of Rp-hplc Method for the Determination of Ropinirole Hydrochloride in Bulk and Pharmaceutical Dosage Forms

Abstract Views: 237  |  PDF Views: 0

Authors

Sowjanya Gummadi
Department of Pharmaceutical Analysis, GITAM Institute of Pharmacy, GITAM (Deemed to be University), Visakhapatnam - 530045, Andhra Pradesh, India
Durga S. Siyyadri
Department of Pharmaceutical Analysis, GITAM Institute of Pharmacy, GITAM (Deemed to be University), Visakhapatnam - 530045, Andhra Pradesh, India

Abstract


A simple, precise, rapid and accurate RP-HPLC method was developed for the estimation of Ropinirole hydrochloride in pure and pharmaceutical dosage forms. The method employed a Phenomenex C8 column (250 × 4.6mm, 5μm) and a mobile phase consisting of 0.1% orthophosphoric acid (pH 2.61) and methanol in the ratio of 50:50 v/v. The flow rate was optimized at 1.2mL/min and the effluents were monitored at 248 nm over a run time of 10.0 min. where the analyte showed the retention at 2.91±0.26 min. The detector response was linear in the concentration of 1-100μg/mL (y = 40236x – 10950). The limit of detection and limit of quantification were found to be 0.0007μg/mL and 0.0021μg/mL respectively. The method was validated as per ICH guidelines and was found to be sensitive, accurate, precise and robust while satisfying all the system suitability. The method was also tested for its stability indicating capability by performing the forced degradation studies and the drug was almost stable in all the exposed conditions with very minor degradations observed. The developed method was used for the assay of the drug in marketed tablets and the percentage assay was found to be 99.32±0.83 %w/w. The results of the study depict that the proposed RP-HPLC method is specific and sensitive for the routine analysis of Ropinirole hydrochloride in bulk drug and in its pharmaceutical dosage form.

Keywords


Ropinirole hydrochloride, RP-HPLC, Validation, Stability indicating, ICH.

References