High-performance liquid chromatographic determination of montelukast sodium in human plasma: Application to bioequivalence study

Abstract

Summary.A simple, sensitive, and precise high-performance liquid chromatographic (HPLC) method for quantitation of montelukast in human plasma has been developed and validated. Commercially available candesartan cilexetil was used as an internal standard. After protein precipitation, montelukast and candesartan cilexetil (I.S.) in human plasma were analyzed using mobile phase containing 62% v/v acetonitrile and 38% v/v buffer (containing 1 mL L −1 triethylamine as peak modifier, final pH adjusted to 2.5 with orthophosphoric acid). Chromatographic separation was achieved on a BDS Hypersil-C18 column (50 × 4.6 mm i.d., particle size 5 μm; Thermo Electron Corporation, USA) using isocratic elution at a flow rate of 1.5 mL min −1 . The signals were monitored using a fluorescence detector set at 350 nm for excitation and 400 nm for emission. The total time for a chromatographic separation was ~3 min. The validated quantitation ranges of this method were 5-300 ng mL −1 with coefficients of variation between 1.75% and 9.38%. Mean recoveries were 91.8 ± 3.8%. The within-and between-batch precisions were 0.74-2.46% and 1.64-7.87%, respectively. The within-and between-batch relative errors (bias) were 0.14-3.3% and 0.08-4.6%, respectively. Stability of montelukast in plasma was >94.7%, with no evidence of degradation during sample processing and 30 days storage in a deep freezer at -70°C. This validated method is sensitive and simple with between-batch precision of <8% and successfully applied for the bioequivalence studies. The formulations were compared using the following pharmacokinetic parameters: AUC 0−t , AUC 0−∞ , and C max . No statistically significant difference (p > 0.05) was observed between the logarithmically transformed AUC 0−t, AUC 0−∞ , and C max values.

A Novel Stability-Indicating Method for Determination of Related Substances of Montelukast Sodium in a Pharmaceutical Dosage Form Using RP-HPLC

“…Literature survey reveals that several methods are reported for the estimation of Montelukast sodium using high-performance liquid chromatography [7,8], reverse phase high-performance liquid chromatography (RP-HPLC) with UV spectrophotometry [9,10], Capillary electrophoresis [11] and cyclic voltammetry [12]. However, there are limited methods for the determination of Montelukast Sodium-related impurities by RP-HPLC.…”

Simultaneous colorimetric detection of four drugs in their pharmaceutical formulations using unmodified gold nanoparticles as a probe

“…Table 1 shows the analytical data of the present method for simultaneous colorimetric detection of four drugs using unmodied Au NPs as a probe. Compared with the performance of chromatographic [7][8][9][10][11][12][13][14] and spectrophotometric [16][17][18][19] methods for detection of four drugs, the present method demonstrated a lowered detection limit and a simplied procedure (without the any sample pretreatment at minimal volume of samples) (Table 2). Although LC-MS is an efficient tool for separation and determination of four drugs independently, the unmodied Au NPs-based colorimetric method is particularly attractive for simultaneous detection of four drugs because the color changes can be easily discerned with the naked-eye and then quantied by UV-visible spectrometry, which avoids tedious sample preparations and complicated instrumentation.…”

“…[1][2][3][4][5][6] Identication and quantication of four drugs (venlafaxine; imipramine; amlodipine; alfuzosin) require a simple, specic and sensitive method for routine analysis of individual drug in biological samples. So far, various analytical techniques including high performance liquid chromatography (HPLC), [7][8][9][10] liquid chromatography with mass spectrometry (LC-MS), 14 capillary electrophoresis, 15 uorescence 16 and UV-visible spectrometry [17][18][19] have been used for the analysis of four drugs independently in pharmaceutical and biological samples. However, some of these methods are expensive, somewhat time consuming, they require derivatization steps and expensive instruments, which makes it unavailable in many laboratories for the analysis of four drugs in biological samples.…”

Selective Consecutive Determination of Desloratadine and Montelukast Sodium in Their Pure and Binary Dosage Form Based on Pencil Graphite Electrochemical Sensors

“…It is a cysteinyl leukotriene receptor antagonist and used for treatment of asthma [ 9 ]. Some research studies were reported to determine MON as individual drug such as HPLC [ 10 , 11 ], spectrophotometric [ 12 , 13 ], and potentiometric [ 14 – 16 ].…”