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Stability Indicating RP–HPLC Method for the Estimation of Acamprosate in Pure and Tablet Dosage Form


Affiliations
1 Department of Pharmaceutical Analysis, SIMS College of Pharmacy, Mangaldas Nagar, Guntur-522 002 (A.P.), India
     

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A simple, fast and precise stability indicating RP - HPLC method was developed for the separation and quantification of Acamprosate in pharmaceutical dosage form. The quantification was carried out using Hypersil C18 4.6X150 mm, 5 μm enhanced polar selectivity column and mobile phase comprised of 0.2M Ammonium acetate and acetonitrile in proportion of ratio 40:60 and degassed under ultrasonication. The flow rate was 1mL/min and the effluent was monitored at 220 nm. The retention time of Acamprosate was 4.187min. The method was validated in terms of linearity, precision, accuracy, specificity, limit of detection and limit of quantitation in accordance with ICH guidelines. Linearity of Acamprosate was in the range of 5 - 30 μg/mL. The percentage recoveries of Acamprosate was 99.00% from the tablet formulation. The stability - indicating capability was established by forced degradation experiments. The proposed method is suitable for determination of Acamprosate in pharmaceutical dosage form.

Keywords

Chromatography, Acamprosate, Forced Degradation, Method Development, Method Validation.
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  • Stability Indicating RP–HPLC Method for the Estimation of Acamprosate in Pure and Tablet Dosage Form

Abstract Views: 218  |  PDF Views: 0

Authors

B. Thangabalan
Department of Pharmaceutical Analysis, SIMS College of Pharmacy, Mangaldas Nagar, Guntur-522 002 (A.P.), India
Avinash Koya
Department of Pharmaceutical Analysis, SIMS College of Pharmacy, Mangaldas Nagar, Guntur-522 002 (A.P.), India
G. Chaitanya
Department of Pharmaceutical Analysis, SIMS College of Pharmacy, Mangaldas Nagar, Guntur-522 002 (A.P.), India
N. Sunitha
Department of Pharmaceutical Analysis, SIMS College of Pharmacy, Mangaldas Nagar, Guntur-522 002 (A.P.), India
S. Manohar Babu
Department of Pharmaceutical Analysis, SIMS College of Pharmacy, Mangaldas Nagar, Guntur-522 002 (A.P.), India

Abstract


A simple, fast and precise stability indicating RP - HPLC method was developed for the separation and quantification of Acamprosate in pharmaceutical dosage form. The quantification was carried out using Hypersil C18 4.6X150 mm, 5 μm enhanced polar selectivity column and mobile phase comprised of 0.2M Ammonium acetate and acetonitrile in proportion of ratio 40:60 and degassed under ultrasonication. The flow rate was 1mL/min and the effluent was monitored at 220 nm. The retention time of Acamprosate was 4.187min. The method was validated in terms of linearity, precision, accuracy, specificity, limit of detection and limit of quantitation in accordance with ICH guidelines. Linearity of Acamprosate was in the range of 5 - 30 μg/mL. The percentage recoveries of Acamprosate was 99.00% from the tablet formulation. The stability - indicating capability was established by forced degradation experiments. The proposed method is suitable for determination of Acamprosate in pharmaceutical dosage form.

Keywords


Chromatography, Acamprosate, Forced Degradation, Method Development, Method Validation.