A validated stability-indicating liquid chromatographic method for determination of process related impurities and degradation behavior of Irbesartan in solid oral dosage

Abstract

The present work describes the development and validation of a stability-indicating RP-HPLC method for the estimation of degradation and process related impurities of Irbesartan, namely Impurity-1, Impurity-2, Impurity-3 and Impurity-4. The developed LC method was validated with respect to specificity, limit of detection and quantification, linearity, precision, accuracy and robustness. The chromatographic separation was achieved on Hypersil Octadecylsilyl (4.6 mm × 150 mm, 3 μm) column by using mobile phase containing a gradient mixture of solvent A (0.55% v/v ortho-phosphoric acid, pH adjusted to 3.2 with triethyl amine) and B (95:5 v/v mixture of acetonitrile and solvent A) at a flow rate of 1.2 mL/min. The detection was carried out at a wavelength of 220 nm. During method validation parameter such as precision, linearity, accuracy, specificity, limit of detection and quantification were evaluated, which remained within acceptable limits. HPLC analytical method is linear, accurate, precise, robust and specific, being able to separate the main drug from its degradation products. The degradation products were well-resolved from the main peak and its impurities, thus proving the stability-indicating power of the method. The method is stability-indicating in nature and can be used for routine analysis of production samples and to check the stability of the Irbesartan HCl tablets.

Development of spectrophotometric method to assay irbesartan in pure and in pharmaceutical dosage form using diazotization reaction

“…and chronic kidney failure . (Weber , 1997), A survey of the literature revealed that several methods have been used to estimate IRBN both purely and in pharmaceutical preparations, directly or indirectly for IRBN, and they include: spectrophotometric methods (Biyani and Yadav, 2019) , (Khalid et al , 2017) , (Jadhav et al , 2014) and (Syeda et al ,2011 ) , HPLC (Alanazi et al , 2014) , (Koyuturk et al , 2014) , (Goswami , 2014) and (Vujić et al , 2012), LC-MS (Qui et al , 2014) and( Chi andChia 2011). The primary objective of the current review was to improve a rational, rapid and modest method for testing irbesartan in its pharmaceutical preparations for routine quality control examination, given spectroscopic analysis, furthermore the procedure has been effectively applied for assurance of IRBN in tablets.…”

Sensitive Extractional Colorimetric Analysis of Fexofenadine Hydrochloride and Irbesartan Bases Through Acid-Dye Complexation Using Naphthol Blue Black in Pure Form and Pharmaceuticals

“…The drug is official in BP [3] and USP [4], which describe HPLC methods for the assay of irbesartan. Few methods have been described for the determination of irbesartan in pharmaceutical dosage forms by HPLC [28][29][30][31][32], extractive spectrophotometry with Picric acid, bromocresol green, bromothymol blue, cobalt thiocyanate and molybdenum (V) thiocyanate [33], spectrophotometry [34][35][36] and HPTLC [37]. Several HPLC [38][39][40][41][42][43][44][45], spectrophotometry [44][45][46][47][48][49][50] and capillary electrophoresis methods [51,52] are reported in the literature for the determination of irbesartan in combined pharmaceutical formulations.…”