Improvement of Determination Method of Acarbose Tablets by High-Performance Liquid Chromatography with Diode Array Detector
XU Shuo, XU Wen-feng, JIN Peng-fei*, WU Xue-jun, KUANG Yong-mei
Beijing Key Laboratory of Drug Clinical Risk and Personalized Medication Evaluation, National Center of Gerontology, Department of Pharmaceutical Science, Beijing Hospital, Beijing 100730, China
Abstract��OBJECTIVE To develop an high-performance liquid chromatography (HPLC) method with diode array detector (DAD) for determination of acarbose in acarbose tablets. METHODS An Alltima C18 column (4.6 mm��250 mm,5 ��m) was used for the separation, with acetonitrile-10 mmol��L-1 ammonium dihydrogen phosphate (containing 0.04% sodium 1-octanesulfonate, adjusted pH to 3.3 with H3PO4) (15��85) as the mobile phase at the flow rate of 0.8 mL��min-1. The detection wavelength was set at 200 nm and the column temperature was maintained at 30 ��. RESULTS The method showed good linearity with a correlation coefficients (r) of 1.000 0. The specificity study demonstrated satisfactory resolutions between acarbose, other ingredients in the drug and forced degradation products. The precision and stability were satisfactory with the relative standard deviations (RSDs) of 0.088% and 0.22%, respectively. The average spiked recovery was 98.49% with RSD of 0.24% (n=9). The content of acarbose in four batches of acarbose tablets was 51.69, 51.75, 51.72 and 51.62 mg��tablet-1, respectively. CONCLUSION The established method is accurate, simple and rapid, and can be utilized for determination of acarbose in acarbose tablets.
CHEN X M. Effect of acarbose and metformin in treatment of impaired glucose tolerance[J]. Chin Med (�й�ҽҩ), 2006, 1(9): 549-550.
[2]
HUANG G Q, LIU S Q, LI J M. Effect of short-term treatment of insulin glargine combined with acarbose on newly diagnosed type 2 diabetes mellitus[J]. J Pract Med (ʵ��ҽѧ��־), 2008, 24(8): 1416-1418.
[3]
HU R J, LI Y, LV Q G, et al. Acarbose monotherapy and type 2 diabetes prevention in eastern and western prediabetes: an ethnicity-specific Meta-analysis[J]. Clin Ther, 2015, 37(8): 1798-1812.
[4]
PAN C Y, GAO Y, CHEN J W, et al. Efficacy of acarbose in Chinese subjects with impaired glucose tolerance[J]. Diabetes Res Clin Pract, 2003, 61(3): 183-190.
[5]
LIU L, ZHANG L S, MEI Y, et al. Meta-analysis on the efficacy of acarbose therapy on Chinese patients with impaired glucose tolerance[J]. Chin Gen Pract (�й�ȫ��ҽѧ), 2013, 16(5B): 1637-1640.
[6]
LIU F, ZHENG W L, LUO Y E, et al. Meta-analysis of domestic vs. imported acarbose tablets for type 2 diabetes mellitus[J]. Chin J Mod Med (�й��ִ�ҽѧ��־), 2014, 24(33): 86-89.
[7]
ZHANG H C. Analysis of curative effect of combined application of acarbose and insulin therapy in treatment of type 2 diabetes[J]. Strait Pharm J (��Ͽҩѧ), 2013, 25(1): 90-91.
[8]
LV X Y, XIE M, CHEN X L. Clinical efficacy of acarbose or repaglinide combined with metformin in the treatment of postprandial hyperglycemia of type 2 diabetes[J]. China Pharm (�й�ҩʦ), 2016, 19(6): 1113-1115.
[9]
LI D L, LI Y, CHEN Y M. Clinical observation of insulin glargine combined with glimepiride and acarbose in treatment of type 2 diabetes with sulfonylurea treatment failure[J]. Drugs Clin(�ִ�ҩ�����ٴ�), 2017, 32(3): 423-427.
[10]
LI J R, DAI J D. 30 Cases of acarbose combined with glipizide in the treatment of elderly patients with type 2 diabetes mellitus[J]. Her Med (ҽҩ����), 2007, 26(5): 510-511.
[11]
WANG W, YOU L D S. Application of oral hypoglycemic agents in our hospital[J]. Northwest Pharm J (����ҩѧ��־), 2010, 25(6): 470-471.
LIU H Y, CHEN H, ZHAO L, et al. Determination of acarbose by RID-HPLC[J]. J Agric Univ Hebei (�ӱ�ũҵ��ѧѧ��), 2007, 30(1): 97-100.
[14]
YANG L, GUO Z Y, ZHANG Y Y, et al. Determination of working reference standard of acarbose by HPLC-ELSD/DAD[J]. West China J Pharm Sci (����ҩѧ��־), 2006, 21(4): 392-393.
[15]
SUN M, WANG X R. Determination of maltose, glucose and acarbose in acarbose fermentation broth by HPLC-ELSD[J]. Chin J Antibiotics (�й���������־), 2011, 36(10): 772-774.
[16]
PENG Y S, WEI C Z. Determination of content and related substances of acarbose capsules by HPLC[J]. West China J Pharm Sci(����ҩѧ��־), 2004, 19(1): 58-59.
[17]
DENG X H. Determination of acarbose in drug substance by HPLC[J]. Anhui Med Pharm J (����ҽҩ), 2005, 9(7): 509.
[18]
LIU Z X, XIE X Y. Prepation and solubility determination of acarbose dispersible tablets[J]. China Pharm (�й�ҩʦ), 2011, 14(11): 1612-1614.
[19]
YANG Y Y, CHEN J Y, LIN M F. Determination of raw material medicine acarbose by UPLC[J]. Pharm Today (����ҩѧ), 2010, 20(6): 27-29.
[20]
RETHFELD L, BLASCHKE G. Analysis of the antidiabetic drug acarbose by capillary electrophoresis[J]. J Chromatogr B, 1997, 700(1-2): 249-253.
[21]
CHERKAOUI S, DAALI Y, CHRISTEN P, et al. Development and validation of liquid chromatography and capillary electrophoresis methods for acarbose determination in pharmaceutical tablets[J]. J Pharm Biomed Anal, 1998, 18(4-5): 729-735.
[22]
ZOU D, HE X R, WU X J, et al. Simultaneous determination of 3 components in compound hypoglycemic preparation by capillary electrophoresis[J]. Chin Hosp Pharm J (�й�ҽԺҩѧ��־), 2006, 26(3): 360-361.
[23]
RETHFELD L, BLASCHKE G. P136 analysis of the antideabetic drug acarbose by capillary electrophoresis[J]. Eur J Pharm Sci, 1994, 2(1-2): 152.
[24]
JIN G Y, XIAO S X. Preparation of poly-aminobenzoic acid modified glassy carbon electrode and application of its in content determination of acarbose[J]. J China Pharm(�й�ҩ��), 2012, 23(29): 2746-2748.
2017, Vol. 52 
