TY - JOUR T1 - Development and Validation of HPLC Method for Determination of Nateglinide in Drug Substances TT - ORIGINAL RESEARCH AU - Hacıoğlu, Aylin AU - Çıtlak, Ayşin AU - Karakuş, Sevgi PY - 2015 DA - April DO - 10.12991/mpj.2015199640 JF - Marmara Pharmaceutical Journal JO - J Res Pharm PB - Marmara University WT - DergiPark SN - 1309-0801 SP - 103 EP - 108 VL - 19 IS - 2 LA - en AB - The scope of this study was the development of a reliable, rapid, simple, sensitive, precise reversed-phase high performance liquid chromatography (RP-HPLC) method was developed and validated for determination of assay of the Nateglinide drug substances. The method was developed on ACE C18 analytical column (150mm x 4.6 mm i.d., particle size 5.0 µm) using a mobile phase of acetonitrile and 0.05% trifluoroacetic acid (25:25, v/v). The elute was monitored with the UV detector at 210 nm with a flow rate of 1.5 mL/min. Calibration curve was linear over the concentration range of 0,2846-1,0125 mg/mL. The retention time of Nateglinide was 7.07 min and the correlation coefficient (r) of the regression equation for the Nateglinide was greater than 0.99 in all cases.KEYWORDS :Nateglinide, HPLC, assay, method validation KW - Nateglinide KW - HPLC assay KW - method validation CR - Terada T, SawadaK, SaitoH, Hashimoto Y, Inui K. Inhibitory effect of novel oral hypoglycemic agent nateglinide (AY4166) on peptide transporters PEPT1 and PEPT2. Eur J Pharmacol 2000; 392: 11–7. CR - Fujita T, Seto Y, Kondo N, Kato R. Studies on the N-[(trans- 4-Isopropylcyclohexyl)-carbonyl]-D.phenylalanine (A-4166) Receptor in HIT T-15 Cells. Displacement of [3H] Glibenclamide. Biochem Pharmacol 1996; 52: 407-11. CR - Bell PM, Cuthbertson J, Patterson S, O’Harte FPM. Additive hypoglycaemic effect of nateglinide and exogenous glucagon- like peptide-1 in type 2 diabetes. Diabetes Res Clin Pract 2011; 91: 68-70. CR - Kim Mi K, Suk Ji H, Kwon MJ, Chung HS , Yoon CS, Jun HJ, Ko JH, Kim TK , Lee SH, Oh MK , Rhee BD, Park JH. Nateglinide and acarbose for postprandial glucose control after optimizing fasting glucose with insulin glargine in patients with type 2 diabetes. Diabetes Res Clin Pract 2011; 92: 322-8. CR - Perfetti R, Ahmad A. Novel sulfonylurea and non- sulfonylurea drugs to promote the secretion of insulin. Trends Endocrin Met 2000; 11: 222-3. CR - Malli D, Gikas E, Vavagiannis A, Kazanis M, Daniilides K, Gennimata D, Panderi I. Determination of nateglinide in human plasma by high-performance liquid chromatography with pre-column derivatization using a coumarin-type fluorescent reagent. Anal Chim Acta 2007; 599: 143–50. CR - Pani NR, Nath L, Singh AV, Mahapatra SK. Development and validation of analytical method for the estimation of nateglinide in rabbit plasma. J Pharmaceut Anal 2012; 2: 492–8. CR - Sankalia JM, Sankalia MG, Sutariya VB, Mashru RC. Nateglinide quantification in rabbit plasma by HPLC: Optimization and application to pharmacokinetic study. J Pharmaceut Biomed Anal 2007; 44: 196–204. CR - Bauer S, Störmer E, Kirchheiner J, Michael C, Brockmöller J, Roots I. Rapid and simple method for the analysis of nateglinide in human plasma using HPLC analysis with UV detection. J Pharmaceut Biomed Anal 2003; 31: 551-/5. CR - Ho EN, Yiu KC, Wan TS, Stewart BD, Watkins KL. Detection of anti-diabetics in equine plasma and urine by liquid chromatography–tandem mass spectrometry. J Chromatogr B Analyt Technol Biomed Life Sci 2004; 811: 65–73. CR - Thomas AB, Patil SD, Nanda RK, Kothapalli LP, Bhosle SS, Deshpande AD. Stability-indicating HPTLC method for simultaneous determination of nateglinide and metformin hydrochloride in pharmaceutical dosage form. Saudi Pharmaceut J 2011; 19: 221–31. CR - Jain S, Bhandari A, Purohit S. Spectrophotometric determination of nateglinide in bulk and tablet dosage forms. Asian J Pharm 2009; 3: 218–21. CR - ICH-Q2(R1) International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Humen Use 2005; http//www.ich.org [Accessed: 20.02. 2015]. UR - https://doi.org/10.12991/mpj.2015199640 L1 - https://dergipark.org.tr/en/download/article-file/166060 ER -