Method Development and Validation for the Determination of Potential Impurities Present in Azilsartan medoxomil Tablets by Reverse Phase-Ultra Performance Liquid Chromatography

Abstract

The present paper describes about precise, sensitive, rapid method for the determination of five potential impurities present in Azilsartan medoxomil Tablets. Separation of impurities at satisfactory level is achieved in Acquity UPLC BEH C 18 , 100 mm length x 2.1 mm id with 1.7 μm particle size column. Mobile phase A consists of 0.1% ortho phosphoric acid in water adjusted the pH to 3.0 with dilute sodium hydroxide and acetonitrile as Mobile phase B using gradient elution mode. Flow rate was kept at 0.5 mL.min -1 with a monitoring wavelength of 215 nm. Developed method was successfully validated as per method validation parameters recommended by International Conference on Harmonisation (ICH) for specificity, linearity, precision, accuracy, determination of LOD, LOQ, solution stability and robustness. The validated Reverse phase-Ultra Performance Liquid Chromatography (RP-UPLC) method was successfully used for quantitative determination of potential known and unknown impurities of Azilsartan medoxomil in Azilsartan medoxomil tablet dosage form, helping to identify the therapeutic efficacy at shorter run time.

Liquid chromatographic method for simultaneous estimation of anti‐hypertensive drug combination Azilsartan Medoxomil and Cilnidipine

“…An extensive literature review reveals that different analytical methods like HPTLC [4,5], RP-HPLC [6][7][8][9][10][11][12], RP-UPLC [13], UV [14], and LC-MS [15,16] have been reported for the estimation of AZL. HPTLC [17][18][19], UV [20][21][22] and RP-HPLC [23][24][25][26][27][28] methods have been reported for analysis of CLN in the bulk and pharmaceutical dosage form.…”

A novel method to determine new potent angiotensin inhibitor, azilsartan, in human plasma via micelle-enhanced spectrofluorimetry using cremophor RH 40

“…A thorough survey of the literature revealed that few reports were published recently for assaying AZL alone in dosage form using highperformance liquid chromatography (HPLC) [14][15][16], UV spectrophotometry [17], highperformance thin layer chromatography (HPTLC) [14,18] and in dog and human plasma using LC/MS [19,20]. AZL in combination with chlorthalidone was also determined in dosage form using UV and fluorescence spectrophotometry [21], HPLC [22][23][24][25] and in human and rat plasma using LC/MS [26].…”