DEVELOPMENT AND VALIDATION OF A DISSOLUTION TEST FOR ACARBOSE IN PURE DRUG AND CONVENTIONAL DOSAGE FORM: A REVIEW

Heena I. Patel*, Kanchan B. Ghatge, Sheetal K. Kamble, Tejaswini S. Kapashe, Sachin S. Mali and Jayshree S. Patil

ABSTRACT

A basic, exact, and precise strategy was created and approved by an UV-spectrophotometric technique for deciding acarbose in unadulterated medication and 50 mg tablet plans. Disintegration testing has arisen in the drug field as a vital device to portray drug item execution. Acarbose, a much of the time endorsed antidiabetic, has no disintegration examine in true monographs. The current examination work meant to create and approve a disintegration test for the quality control of Acarbose by ICH rule tablets containing 50 mg of dynamic drug fixing (Programming interface). Comes about because of testing sink conditions and steadiness at 37 °C show that acarbose is steady in water. In vitro disintegration trial of Acarbose tablets were performed utilizing different test conditions however consistently under sink conditions. The impacts of filtration and deaeration were assessed. The most prejudicial test conditions were palatable: water (900 mL at 37 ± 0.5°C) as disintegration medium, paddle strategy (Contraption 2), 100 rpm, and 30 min. The UV spectrophotometric technique for assurance of delivered acarbose was created and approved. The strategy introduced linearity (r2 = 0.996) in the 27.5-82.5 μg/ml fixation range. The recuperations were great, going from 97.06% to 100.17%. The intraday and interlay accuracy results were 1.0587 % and 0.3952% RSD, separately. The created disintegration test is satisfactory for its motivation and can be applied for the quality control of 50-mg Acarbose tablets.

Keywords: Acarbose unadulterated medication, Disintegration contraption, Sodium chloride, Hydrochloric corrosive (37%), water.