910 ISSN 1061-9348, Journal of Analytical Chemistry, 2018, Vol. 73, No. 9, pp. 910–916. © Pleiades Publishing, Ltd., 2018. Development and Validation of a Stability-Indicating HPLC Method for the Determination of Acarbose in Pharmaceutical Dosage Forms 1 Azam Sadat Montazeri a, b , Ali Mohammadi b, *, Noushin Adib c , and Ali Naeemy b a Vice–Chancellery of Food and Drug, Shahroud University of Medical Sciences, Shahroud, Iran b Pharmaceutical Quality Assurance Research Centre, Faculty of Pharmacy, Tehran University of Medical Sciences, P.O. Box 14155–645, Tehran, Iran c Food and Drug Research Center, Food and Drug Organization, MOH & ME, Tehran, Iran *e-mail: alimohammadi@tums.ac.ir Received September 8, 2016; in final form, October 7, 2017 Abstract⎯The United States Pharmacopeia 39 uses an HPLC–UV method for the assay of acarbose and its impurities in bulk form. However, there is no information about the stability-indicating nature of the pro- posed method for the assay of acarbose in tablets. Therefore, in this study, stress tests were firstly applied on the bulk and drug product based on International Conference on Harmonization. Then, verification and revalidation of the proposed method were performed using stressed and untreated samples. Separation was achieved on a Lichrospher ® ‒100–NH 2 , 5 μm, 250 × 4.6 mm i.d. column using a mobile phase consisting of acetonitrile–0.007 M phosphate buffer (pH 6.7) (750 : 250, v/v) at a flow rate of 2 mL/min and UV detection at 210 nm. The column was maintained at 35°C and an injection volume of 10 μL was used. The linearity of the developed method was investigated in the range of 2.5–20 mg/mL (R 2 = 0.9995). Peak purity results using a diode array detector have shown that degradation products did not interfere with the detection of acarbose and the assay can thus be considered stability-indicating. Keywords: acarbose, stability-indicating, HPLC, stress test DOI: 10.1134/S1061934818090071 Acarbose (Ac) (Scheme 1) is produced by certain strains of Actinoplanes utahensis. It contains not less than 95% and not more than 102% of Ac (C 25 H 43 NO 18 ) calculated on the anhydrous basis [1]. This drug is used for the treatment of type 2 diabetes mellitus, which is a complex progressive disorder noted for its morbidity and mortality. It is epidemic in many industrialized and developing countries and, as such, is considered to be one of the most challenging health problems of the 21st century. Scheme 1. Chemical structure of acarbose. Acarbose, among other drugs, has shown favorable therapeutic effects compared to sulfonylureas, espe- cially in terms of reducing the rate of disease progres- sion [2]. Controlling and minimizing the side effects of drugs are the key issues in assuring the safety of drug therapy. In the case of bulk drug materials, purity among other main attributes of drug quality is of prominent importance, whereas strength is an import- ant quality attribute of drug formulations [3]. Several analytical methods including HPLC [4‒7], capillary electrophoresis [7, 8] and spectrophotometery [9] have been published for the determination of Ac in bulk or pharmaceutical dosage forms. Regulatory guidance provided in International Conference on Harmonization (ICH) [10, 11] requires the develop- ment and validation of stability-indicating procedures 1 The article is published in the original. HO OH HN HO OH O OH O H 3 C HO O OH O HO OH O OH OH HO OH ARTICLES