DEVELOPMENT AND VALIDATION OF STABILITY INDICATING METHOD RP-HPLC METHOD OF ACOTIAMIDE

  • Charu P. Pandya Quality Assurance Laboratory, Centre of Relevance and Excellence in Novel Drug Delivery System, Faculty of Pharmacy, Shri G. H. Patel Pharmacy Building, The Maharaja Sayajirao University of Baroda, Fatehgunj, Vadodara, 390002, Gujarat, India
  • Sadhana J. Rajput Quality Assurance Laboratory, Centre of Relevance and Excellence in Novel Drug Delivery System, Faculty of Pharmacy, Shri G. H. Patel Pharmacy Building, The Maharaja Sayajirao University of Baroda, Fatehgunj, Vadodara, 390002, Gujarat, India

Abstract

Objective: The objective of present work was to develop and validate simple, precise, accurate and specific stability indicating method for determination of acotiamide in presence of its degradation products.

Methods: An isocratic RP-HPLC method has been developed using C-8 Thermo Hypersil BDS Column (250 x 4.6 mm i.d., 5µparticle size) with the mobile phase composition of acetonitrile: 0.1 % triethylamine in 0.2% formic acid (30: 70) at column oven temperature of 40 °C. The flow rate was 1.0 ml min-1 and effluent was detected at 282 nm. The method was validated in terms of linearity, accuracy, precision, LOD (Limit of Detection), LOQ (Limit of Quantification) and robustness as per ICH guidelines.

Results: The method was found to be linear in the range of 10-60µg/ml. Limit of detection and limit of quantification was found to 0.36µg/ml and 1.10 µg/ml.% Recovery was found to be in the range of 99.45%-99.75%and precision less than 2%. The developed method was successfully applied for estimation of Acotiamide in marketed tablet formulation and percentage assay was found to be 100.45%. Acotiamide was subjected to stress degradation under acid, base, neutral hydrolysis, oxidation, dry heat, photolysis conditions. Significant degradation was observed in acid and base degradation.

Conclusion: The developed RP-HPLC method was simple, rapid, accurate, precise and stability indicating for the estimation of Acotiamide in bulk and tablet dosage form.

Keywords: Acotiamide, Reverse Phase High Performance Liquid Chromatography(RP HPLC), Stability Indicating Assay Methods (SIAM’s), Stress Degradation, ICH Q1A(R2), Q2R1

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References

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Pandya, C. P., and S. J. Rajput. “DEVELOPMENT AND VALIDATION OF STABILITY INDICATING METHOD RP-HPLC METHOD OF ACOTIAMIDE”. International Journal of Pharmacy and Pharmaceutical Sciences, Vol. 10, no. 9, Sept. 2018, pp. 1-8, doi:10.22159/ijpps.2018v10i9.24925.
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