Validated Stability-Indicating HPLC Method for the Determination of Mesna in Presence of Its Degradation Products

Abstract

A rapid and simple stability-indicating liquid chromatographic method was developed and validated for analysis of mesna in the presence of its degradation products in drug substance and drug products in a run time not >5 min. The separation was achieved on a RP amide C16 column at room temperature using methanol-phosphate buffer (10:90, v/v, pH 3.0) as mobile phase at a flow rate of 1 mL min(-1) and UV detection at 210 nm. The detector response for mesna was linear over the selected concentration range from 50 to 1000 µg mL(-1) with a correlation coefficient 0.9998. The limit of detection and the limit of quantitation were 7.5 and 22.7 µg mL(-1), respectively. The solution was stable for at least 5 days. Baseline resolution between mesna and its degradation products was achieved. Diode array detection peak purity tests showed no peak interfered with mesna peak. Moreover, the method was successfully applied for the determination of mesna in two different commercially available drug products.

Kinetic fluorimetric determination of Mesna (Sodium-2-mercaptoethane sulfonate) in drug products through oxidation with cerium(IV)

“…The limit of detection (LOD) was determined by evaluating the lowest concentration of the analyte that can be readily detected and was found to be 0.17 ng/mL. LOQ and LOD were calculated according to the equations (7) and (8).…”

“…3 ó / S ( 8 ) where ó is the standard deviation of the intercept of regression line and S is the slope of the calibration curve. …”

“…Unchanged mesna has free thiol group that reacts with ifosfamide and cyclophosphamide including acrolein considered to be responsible for toxic effect on bladder, In addition, mesna has been used for a long time as a mucolytic agent that breaks disulfide bonds of mucous polypeptide chains [1]. Some analytical methods have been reported for determination of studied drug, the reported method for mesna includes High Performance Liquid Chromatography (HPLC-UV) [2], HPLC with electrochemical detection [3] Vibrational Spectroscopic studies [4], HPLC-with fluorescence detection [5], Spectrophotometric method [6,7] Kinetic Spectrophotometric method [8].…”

Novel MEKC method for determination of sodium 2-mercaptoethanesulfonate in human plasma with in-capillary derivatization and UV detection

“…In urine free thiol group of mesna reacts with ifosfamide and cyclophosphamide, responsible for the toxic effect on bladder, affording harmless to the mucous membrane derivatives [1][2][3][4]. Ifosfamide, an oxazaphosphorine alkylating agent is concurrently administered with the uroprotective mesna, which prevents the occurrence of hemorrhagic cystitis.…”

“…Formed in the blood by the autoxidation inactive disulfide of mesna − dimesna can be back converted to reduced active form in the renal tubule cells, thereby inactivating toxins like acrolein to the bladder. Moreover, mesna acts as mucolytic drug that efficiently cleaves disulfide bonds of mucus polypeptides [2][3][4][5][6]. Due to the small molecular size, mesna is prone to concentrate especially in kidneys [1,7].…”