Development and Validation of HPLC Method for Determination of Nateglinide in Drug Substances

Yıl 2015, Cilt: 19 Sayı: 2, 103 - 108, 10.04.2015

Aylin Hacıoğlu Ayşin Çıtlak Sevgi Karakuş

Öz

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

Anahtar Kelimeler

Nateglinide, HPLC assay, method validation

ORIGINAL RESEARCH

Öz

Kaynakça

• 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.
• 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.
• 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.
• 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.
• Perfetti R, Ahmad A. Novel sulfonylurea and non- sulfonylurea drugs to promote the secretion of insulin. Trends Endocrin Met 2000; 11: 222-3.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• Jain S, Bhandari A, Purohit S. Spectrophotometric determination of nateglinide in bulk and tablet dosage forms. Asian J Pharm 2009; 3: 218–21.
• 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].