Chinese Journal of Pharmacovigilance ›› 2016, Vol. 13 ›› Issue (7): 403-407.

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Consistency Evaluation of Dissolubility of Indapamide Tablets between Generic and Original Preparation

ZHANG Xiang1, SONG Jin-chun1, CHEN Li2   

  1. 1Renmin Hospital of Wuhan University, Hubei Wuhan 430060, China;
    2School of Pharmacy, Wuhan University, Hubei Wuhan 430072, China
  • Received:2016-06-06 Revised:2018-07-17 Online:2016-07-20 Published:2018-07-17

Abstract: Objective To compare the dissolubility of three different domestic indapamide tablets with the original preparation in vitro, so as to evaluate the consistency. Methods HPLC method was adopted. The column was Agilent TC-C18, mobile phase was methanol-water-glacial acetic acid (55:45:0.1, V/V) with a flow rate of 1 mL·min-1, the detection wavelength was 240 nm, the column temperature was 30℃, the injection volume was 20 μL. The stirring paddle method was adopted, volume of dissolution medium was 900 mL and roating rate was 50 rpm. The dissolution mediums were water, hydrochloric acid solution (pH1.2), acetic acid-sodium acetate buffer solution (pH4.0) and phosphate buffer solution (pH6.8). The similarity of dissolution profile was evaluated by calculating similar factor (f2). Results Only the generic drug C has similar dissolution profile from reference preparation D, the consistency of dissolubility of A and B was considerablely different. Conclusion The dissolution profiles of some domestic indapamide tablets are not consistent with its original product in vitro, the production process needs to be further improved.

Key words: indapamide tablet, generic preparation, original preparation, dissolution profile

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