RP-HPLC METHOD FOR ESTIMATION OF TIAPRIDE RELATED SUBSTANCE IN TABLET FORMULATION

Authors

  • Jwal Doctor (Astron division) Intas Pharmaceuticals Ltd. Ahmedabad
  • Komal Chaudhary Nirma University
  • Dharmin Joshi (Astron division) Intas Pharmaceuticals Ltd. Ahmedabad
  • Sanjay Prajapati (Astron division) Intas Pharmaceuticals Ltd. Ahmedabad
  • Priti J Mehta Institute of Pharmacy, Nirma University, S. G Highway Ahmedabad 382481

Keywords:

HPLC, LC-MS, Forced degradation, ICH guidelines, Tiapride Hydrochloride

Abstract

Objective: To develop a simple, precise, accurate related substance, reverse phase high-performance liquid chomatographic (RP-HPLC) method for the quantitative estimation of impurities which are present in dosage form of Tiapride Hydrochloride.

Methods: The chomatographic separation was achieved with Inertsil C8 (250 × 4.6) mm, 5µ column with mobile phase containing a gradient mixture of 0.05 mM aqueous sodiumdihydrogen phosphate (KH2PO4)solution buffer: (with octanesulphonate and final pH of buffer was adjusted to 2.7 with Orthophosphoric acid): Acetonitrile: Methanol (800:150:50 v/v), flow rate of 1.5 ml/min and a detection wavelength of 240 nm.

Results: The method exhibited linearity between range 0.125 to 1200 µg/ml, shows well resolved degradation products from Tiapride hydrochloride tablet with 0.063 µg/ml of LOD (limit of detection) and 0.125 µg/ml of LOQ (limit of Quantification). Forced degradation studies proved that the method is specific for Tiapride Hydrochloride and N-oxide Tiapride reported in European pharmacopeia and British pharmacopeia is one of the degradation impurity confirmed by liquid chromatography mass spectrometry (LC-MS) analysis.

Conclusion: An accurate, precise, linear, robust and specific related substance RP-HPLC method was developed and validated for the quantitative estimation of impurities presented in pharmaceutical dosage form of Tiapride Hydrochloride as per ICH guidelines. The method is stability indicating used for separation of degradation products and can be used for the identification of process related impurity.

 

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Author Biography

Priti J Mehta, Institute of Pharmacy, Nirma University, S. G Highway Ahmedabad 382481

Pharmaceutical Analysis, HOD of department of pharmaceutical analysis

References

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Published

01-11-2015

How to Cite

Doctor, J., K. Chaudhary, D. Joshi, S. Prajapati, and P. J. Mehta. “RP-HPLC METHOD FOR ESTIMATION OF TIAPRIDE RELATED SUBSTANCE IN TABLET FORMULATION”. International Journal of Pharmacy and Pharmaceutical Sciences, vol. 7, no. 11, Nov. 2015, pp. 294-9, https://innovareacademics.in/journals/index.php/ijpps/article/view/7063.

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