The Development and Validation of Fast and Robust Stability Indicating RP-HPLC Method for Simultaneous Estimation of Azilsartan Medoxomil and Cilnidipine in Pharmaceutical Dosage Form

Abstract

Objectives: A selective, precise and accurate RP-HPLC stability indicating assay method has been developed for the simultaneous estimation of Azilsartan medoxomil and Cilnidipine in tablet dosage form. Materials and Methods: The efficient chromatographic separation of drug was achieved by using C 18 (150mm×4.6mm, Agilent 5µm) Column at ambient temperature. Mobile phase contains triethylamine buffer (pH 3.5 adjusted with ortho-phosphoric acid) and acetonitrile (40:60 V/V). Flow rate of mobile phase 1.0 ml/min using isocratic mode .Wavelength selected at 249 nm by using photo diode array detector. Results: The retention time of Azilsartan medoxomil peak 1, Azilsartan medoxomil peak 2 and Cilnidipine were noticed to be 2.16 min, 3.90 min and 9.52 min respectively. The linearity range for Azilsartan medoxomil and Cilnidipine were found to be 50 -150 µg/ml and 12.5-37.5 µg/ml and percent recoveries were noticed to be 99.27±0.58 and 98.65±0.49 respectively. Various stress testing conditions such applied to the drug ingredients and drug formulation. The degradants and drugs efficiently separated by using enhanced chromatographic conditions. The developed method was validated as per recommendation parameters of International council on harmonization guideline Q2(R1). Conclusion:The validation parameters stated that the drug substances were efficiently separated from its degradants and developed method can be routinely applied for the simultaneous estimation of Azilsartan medoxomil and Cilnidipine in tablet formulation in a laboratory.

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

“…The method was validated as per ICH Q2 (R1) guideline. Compared to the reported method [31], the developed method is more sensitive and economical and there is no statistically significant difference in the assay results (95% confidence interval) of developed and reported liquid chromatographic methods. The forced degradation studies revealed that AZL was susceptible to acid‐base hydrolysis, thermal condition, oxidative degradation, and photolytic degradation, while CLN was found to be stable in all degradation studies.…”

“…For estimation of a combined dosage form of AZL and CLN, UV [29], HPLC [30][31], and HPTLC [32] methods have been reported. The reported UV method [29] was developed using the simultaneous equation method.…”

“…The reported HPLC method [30] shows the estimation of AZL and CLN in combined dosage form without stress testing. While another method [31] reports stability indicating the LC method for estimation of AZL and CLN in combined dosage form, but it lacks sensitivity and uses a costlier solvent as a mobile phase. So it was thought to develop a sensitive, robust, and economical stability-indicating LC method for the estimation of AZL and CLN in the combined dosage form.…”

Analytical Review on Newly Approved Antidiabetic and Antihypertensive Drugs

“…61 • Azilsartan On 09.07.2018, azilsartan, combined with chlorthalidone, for managing hypertension in adults. Azilsartan medoxomil was quantified using RP-HPLC 62 and HPTLC. 63 Azilsartan medoxomil and chlorthalidone were quantified using UV and HPTLC methods.…”

Green analytical chemistry‐driven response surface modeling to stability‐indicating chromatographic method for estimation of cilnidipine and application of high‐performance thin‐layer chromatography–mass spectrometry for characterization of degradation products

“…Cilnidipine (CIL) is a calcium channel blocker used to treat heart conditions such as angina and excessive blood pressure [18]. According to the literature study, several stability-indicating RP-HPLC methods have been reported for the estimation of CIL alone and with other drugs [19][20][21][22][23][24][25]. Methanol and acetonitrile were used as mobile phase components and diluents for sample pretreatment in the reported chromatographic procedures.…”