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Year : 2015   |  Volume : 3   |  Issue : 1   |  Page : 8-14  

Stability-indicating high-performance thin-layer chromatographic (HPTLC) method for estimation of Pramipexole dihydrochloride

Jain P.S. Gorle A., Patil S., Chavan R., Bari P., Surana S

Correspondence Address:R. C. Patel Institute of Pharmaceutical Education and Research, Shirpur Dist: Dhule (M.S.) 425 405 India

Source of Support: , Conflict of Interest: None


DOI: 10.4103/2231-4040.197331

Abstract  

A simple, selective, precise and Stability-indicating High-performance thin-layer chromatographic method for analysis of Pramipexole dihydrochloride both in a bulk and in pharmaceutical formulation has been developed and validated. The method employed, HPTLC aluminium plates precoated with silica gel as the stationary phase. The solvent system consisted of n-hexane: ethanol: ammonia (3.5: 6: 0.5 v/v). The system was found to give compact spot for Pramipexole dihydrochloride (Rf value of 0.43±0.02). Densitometric analysis of Pramipexole dihydrochloride was carried out in the absorbance mode at 261 nm. The linear regression analysis data for the calibration plots showed good linear relationship with r2 = 0.999±0.0001 with respect to peak area in the concentration range 100 - 600 ng per spot. The method was validated for precision, recovery and robustness. The limits of detection and quantification were 3.57 and 10.82 ng per spot, respectively. Pramipexole dihydrochloride was subjected to acid and alkali hydrolysis, oxidation and thermal degradation. The drug undergoes degradation under acidic, basic, oxidation and thermal conditions. This indicates that the drug is susceptible to acid, base, oxidation and thermal conditions. The degraded product was well resolved from the pure drug with significantly different Rf value. Statistical analysis proves that the method is repeatable, selective and accurate for the estimation of investigated drug. The proposed developed HPTLC method can be applied for identification and quantitative determination of Pramipexole dihydrochloride in bulk drug and pharmaceutical formulation.

Keywords: Pramipexole Dihydrochloride; HPTLC; Validation; Stability; Degradation.

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