Abstract
A simple, rapid, and precise high-performance thin-layer chromatographic (HPTLC) method for simultaneous estimation of two antidiabetic drugs, metformin hydrochloride and sitagliptin phosphate, in tablet dosage form has been developed and validated. Chromatography was performed on silica gel 60 F<sub >254</sub> plates with butanol : water : glacial acetic acid (6 : 2 : 2, v/v/v) as mobile phase. This system gave a good resolution for metformin hydrochloride (<svg style="vertical-align:-5.76988pt;width:19.3375px;" id="M1" height="18.362499" version="1.1" viewBox="0 0 19.3375 18.362499" width="19.3375" xmlns:xlink="http://www.w3.org/1999/xlink" xmlns="http://www.w3.org/2000/svg"> <g transform="matrix(.017,-0,0,-.017,.062,11.113)"><path id="x1D445" d="M627 18l-10 -26q-79 6 -116 27t-69 76q-41 71 -71 138q-13 29 -27.5 39t-42.5 10h-46l-27 -145q-13 -74 -2.5 -88.5t78.5 -20.5l-6 -28h-271l5 28q66 6 82.5 21.5t30.5 87.5l71 387q12 66 2 78.5t-77 19.5l8 28h233q102 0 147 -29q65 -43 65 -129q0 -69 -45.5 -117
t-115.5 -72q40 -86 66 -133q39 -68 65 -101q28 -37 73 -51zM491 483q0 67 -33.5 101t-91.5 34q-35 0 -51 -10q-13 -8 -20 -48l-45 -245h49q71 0 113 28q79 52 79 140z" /></g> <g transform="matrix(.012,-0,0,-.012,11.013,15.188)"><path id="x1D453" d="M619 670q0 -13 -9 -26t-18 -19q-13 -10 -25 2q-36 38 -66 38q-31 0 -54.5 -50t-45.5 -185h120l-20 -31l-107 -12q-23 -138 -57 -293q-27 -122 -55 -184.5t-75 -109.5q-60 -61 -114 -61q-25 0 -47.5 15t-22.5 31q0 17 31 44q11 8 20 -1q10 -11 31 -19t35 -8q26 0 47 19
q34 34 71 253l54 315h-90l-3 12l31 30h70q28 138 90 204q35 37 75 57.5t70 20.5q26 0 45 -14t19 -28z" /></g> </svg> value of 0.35 ± 0.01) and sitagliptin phosphate (<svg style="vertical-align:-5.76988pt;width:19.3375px;" id="M2" height="18.362499" version="1.1" viewBox="0 0 19.3375 18.362499" width="19.3375" xmlns:xlink="http://www.w3.org/1999/xlink" xmlns="http://www.w3.org/2000/svg"> <g transform="matrix(.017,-0,0,-.017,.062,11.113)"><use xlink:href="#x1D445"/></g> <g transform="matrix(.012,-0,0,-.012,11.013,15.188)"><use xlink:href="#x1D453"/></g> </svg> value of 0.75 ± 0.01). Detection and quantification were carried out at 227 nm. The linear regression data for the calibration plot showed a good relationship with <svg style="vertical-align:-0.20474pt;width:71.387497px;" id="M3" height="11.175" version="1.1" viewBox="0 0 71.387497 11.175" width="71.387497" xmlns:xlink="http://www.w3.org/1999/xlink" xmlns="http://www.w3.org/2000/svg"> <g transform="matrix(.017,-0,0,-.017,.062,10.862)"><path id="x1D45F" d="M393 379q-9 -16 -28 -29q-15 -10 -23 -2q-19 19 -36 19q-21 0 -52 -38q-57 -72 -82 -126l-40 -197q-23 -3 -75 -18l-7 7q49 196 74 335q7 43 -2 43q-7 0 -30 -14.5t-47 -37.5l-16 23q37 42 82 73t67 31q41 0 15 -113l-11 -50h4q41 71 85 117t77 46q29 0 45 -26
q13 -21 0 -43z" /></g><g transform="matrix(.017,-0,0,-.017,11.945,10.862)"><path id="x3D" d="M535 323h-483v50h483v-50zM535 138h-483v50h483v-50z" /></g><g transform="matrix(.017,-0,0,-.017,26.649,10.862)"><path id="x30" d="M241 635q53 0 94 -28.5t63.5 -76t33.5 -102.5t11 -116q0 -58 -11 -112.5t-34 -103.5t-63.5 -78.5t-94.5 -29.5t-95 28t-64.5 75t-34.5 102.5t-11 118.5q0 58 11.5 112.5t34.5 103t64.5 78t95.5 29.5zM238 602q-32 0 -55.5 -25t-35.5 -68t-17.5 -91t-5.5 -105
q0 -76 10 -138.5t37 -107.5t69 -45q32 0 55.5 25t35.5 68.5t17.5 91.5t5.5 105t-5.5 105.5t-18 92t-36 68t-56.5 24.5z" /></g><g transform="matrix(.017,-0,0,-.017,34.808,10.862)"><path id="x2E" d="M113 -12q-24 0 -39.5 16t-15.5 42q0 24 16 40.5t40 16.5t40 -16.5t16 -40.5q0 -26 -16 -42t-41 -16z" /></g><g transform="matrix(.017,-0,0,-.017,38.684,10.862)"><path id="x39" d="M244 635q90 0 143 -72t53 -177q0 -133 -65 -229.5t-171 -139.5q-79 -32 -140 -32l-5 30q109 18 185 91t101 186l-68 -36q-29 -16 -60 -16q-79 0 -129 51.5t-50 130.5q0 80 57 146.5t149 66.5zM228 602q-52 0 -78 -45.5t-26 -98.5q0 -69 36.5 -115.5t97.5 -46.5
q53 0 90 28q4 31 4 66q0 51 -9.5 95.5t-39 80.5t-75.5 36z" /></g><g transform="matrix(.017,-0,0,-.017,46.843,10.862)"><use xlink:href="#x39"/></g><g transform="matrix(.017,-0,0,-.017,55.002,10.862)"><use xlink:href="#x39"/></g><g transform="matrix(.017,-0,0,-.017,63.162,10.862)"><path id="x35" d="M153 550l-26 -186q79 31 111 31q90 0 141.5 -51t51.5 -119q0 -93 -89 -166q-85 -69 -173 -71q-32 0 -61.5 11.5t-41.5 23.5q-18 17 -17 34q2 16 22 33q14 9 26 -1q61 -50 124 -50q60 0 93 43.5t33 104.5q0 69 -41.5 110t-121.5 41q-53 0 -102 -20l38 305h286l6 -8
l-26 -65h-233z" /></g> </svg> and 0.9991 for metformin hydrochloride and sitagliptin phosphate, respectively. The method was validated for precision and recovery. The limits of detection and quantification were 13.05 and 39.56 ng/<i >μ</i>L for metformin hydrochloride and 2.65 and 8.03 ng/<i >μ</i>L for sitagliptin phosphate, respectively. The amounts of the drugs in the marketed formulation were 99.86% and 98.91% for metformin hydrochloride and sitagliptin phosphate, respectively.
Highlights
Metformin hydrochloride (MET), N, N-dimethylimidodicarbonimidic diamide monohydrochloride (Figure 1(a)), is an antihyperglycemic agent that improves glucose tolerance in patient with type II diabetes, lowering both basal and postprandial plasma glucose
Sitagliptin phosphate (SITA) increased incretin levels (GLP-1 and GIP) which inhibit glucagon release, in turn decreases blood glucose, but more signi cantly increases insulin secretion; this suppresses the release of glucagon from the pancreas and drives down blood sugar levels [2]
A literature survey revealed that MET is official in IP [4], BP [3], and USPNF [5], while SITA is not yet official in any of the pharmacopoeia
Summary
Metformin hydrochloride (MET), N, N-dimethylimidodicarbonimidic diamide monohydrochloride (Figure 1(a)), is an antihyperglycemic agent that improves glucose tolerance in patient with type II diabetes, lowering both basal and postprandial plasma glucose. Determination of MET and SITA in tablet dosage form by liquid chromatography has been reported [8]. Previous analysis, fresh stationary and mobile phases for each analysis with no contamination, the ability for visual detection with an open system, and to determine nonUV absorbing compounds detected by postchromatographic derivatization. It reveals that proposed method require less time and less solvent for the analysis. Proposed method is cost effective as HPLC grade solvents are too costly
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