Stability Indicating RP-HPLC Method Development and Validation for Simultaneous Quantification of 15 Organic Impurities of Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide in Combined Dosage Form

Desai, Pritesh R.; Mehta, Priti; Chokshi, Avani

doi:10.1007/s10337-019-03718-9

Cited by 10 publications

(8 citation statements)

References 25 publications

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“…It is recommended for the treatment of high blood pressure and sold as Olmetec® [1,2]. Chemically 5-(2hydroxypropan-2-yl)-2-propyl-3-({4-(2-(2H-tetrazol 5yl) phenyl) phenyl} methyl) imidazole-4carboxylic acid and its molecular weight is 446.501 gm/mol [3,4]. Atorvastatin (Lipitor) is a drug class known as statins.…”

Section: Introductionmentioning

confidence: 99%

Response Surface Method for the Simultaneous Estimation of Atorvastatin and Olmesartan

et al. 2022

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The simultaneous estimation of Atorvastatin Calcium (ATS) and Olmesartan Medoxomil (OLM) in bulk and pharmaceutical dosage forms, a new, quick, and cost-effective Reverse Phase High Performance Liquid Chromatography (RP-HPLC) method has been developed. The experimental design was used to achieve multivariate optimization of the RP-HPLC experimental conditions. Three independent variables were used to create mathematical models: Acetonitrile content in the mobile phase composition, buffer pH, and flow rate. Here, the applied model was central composite design (CCD) to research the response surface methodology and study the effects of independent factors. The Shimadzu (LC 20 AT VP) HPLC system with Spinchrom software has been used. Zodiac, C18 (250×4.6 ID) 5μm column, phosphate buffers, and acetonitrile were used as mobile phase in the ratio 40:60 v/v with a flow rate 1.15 mL/min. The eluent was monitored at 212 nm using the Prominence UV-Visible detector. The retention time for OLM and ATS was 2.673 and 3.717, respectively. The optimized procedure was validated as per ICH guidelines. The correlation coefficient of OLM and ATS was 0.9869 and 0.9832. The % of recovery was 98.59, 99.68 %. OLM had a LOD of 17.568 μg/mL, while ATS had a LOD of 12.88 μg/mL. OLM had a LOQ of 53.24 μg/mL, while ATS had a LOQ of 39.04 μg/mL. The pH aqueous phase, solvent composition, and flow rate were the most stringent variables affecting the responses, according to the 3D response surface graphs. A new accurate and precise RP-HPLC approach has been developed and validated and used to regularly analyse OLM and ATS. HIGHLIGHTS A new, quick, and cost-effective RP-HPLC method for the simultaneous estimation of Atorvastatin Calcium and Olmesartan Medoxomil in bulk and pharmaceutical dosage forms RP-HPLC method developed by experimental design and response surface method Developed method was validated as per ICH guidelines GRAPHICAL ABSTRACT

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Section: Introductionmentioning

confidence: 99%

Response Surface Method for the Simultaneous Estimation of Atorvastatin and Olmesartan

et al. 2022

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“…Candesartan Cilexitil is official in JP 2016 [16], USP 2015 [17] and BP 2020 [18] and analysed by Liquid chromatography. A review of the literature reveals that several analytical procedures have been published for the quantification of Amlodipine Besylate including different methods viz; spectrophotometric [19,20], HPLC [21][22][23][24][25], stability-indicating RP-HPLC [26], in human plasma by HPLC-MS [27] and HPTLC method [28,29] as alone and in combined dosage forms with other drugs. For Candesartan Cilexetil, the different methods reported are UV method [30][31][32][33], HPLC [34][35][36], stability-indicating RP-HPLC [37], HPTLC [38] and UPLC method [39].…”

Section: Introductionmentioning

confidence: 99%

Simultaneous Evaluation of Amlodipine Besylate and Candesartan Cilexetil by Applying Chemometric Assisted Spectrophotometric Method

Hinge¹,

Patel²,

Shah³

2022

Pharmacophore

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Two distinct spectrophotometric methods are provided in this paper for simultaneous measurement of Amlodipine Besylate and Candesartan Cilexetil in bulk and formulation. Two chemometric approaches were used to quantitatively resolve overlapping spectra, Inverse least squares (ILS) and the Classical least square method (CLS). Calibration curves were plotted using the absorbance and concentration of mixed solutions of two drugs. The drugs; Amlodipine Besylate and Candesartan Cilexetil were found to be linear in the 5-15 and 8-24 µg/ml range. The data matrix of absorbance was generated by determining absorbance in a wavelength range from 300 to 360 nm. A calibration set composition of concentration of a different mixture of Amlodipine Besylate and Candesartan Cilexetil was assembled statistically to optimize the particulate content from the spectra in a way to get minimal errors in multivariate calibrations. The algorithms of CLS and ILS were applied to spectra of the mixed solution of two drugs in a calibration set and a suitable matrix was acquired. The model from CLS and ILS was selected by studying the values of RMSEP. Then this algorithm was applied to the prediction set of different mixtures of two drugs and marketed formulation. The results of the recovery study of the marketed formulation were determined with great sensitivity in terms of limit of detection and limit of quantification. These CLS and ILS methods are validated and employed for the quantification of drugs in mixtures and formulation.

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“…Several methods have been reported to simultaneously determine HCT, AML, and OML in combined dosage form by HPLC [19–20] and UPLC [21]. Additionally, we evaluated the related substances for each combination of HCT, AML, and OLM [1, 22].…”

Section: Introductionmentioning

confidence: 99%

LC–MS/MS and in silico analysis of pharmaceutical impurities in a combination drug for hypertension

Kim

Jung

Bae

et al. 2022

Separation Science Plus

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This study intends to develop an essential simultaneous analysis method for the stability study of the combination drugs hydrochlorothiazide, (S)-amlodipine besylate, and olmesartan medoxomil and identify degradation products. A stress test of the combination drug was performed under thermal/humidity conditions to identify decomposition products expected to be generated under long-term storage conditions. Six unidentified degradation products were generated from (S)-amlodipine besylate and olmesartan medoxomil, except for those identified.Unspecified degradation products were identified by degradation prediction software with LC-MS/MS, and genotoxicity was predicted by toxicity prediction software. In silico toxicity, six degradation products were expected to be nonmutagenic. This study describes the development of an analytical method to predict degradation products and determine whether the degradation products are genotoxic. This process will be helpful in further forced degradation studies to predict the toxicity of potential impurities.

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Stability Indicating RP-HPLC Method Development and Validation for Simultaneous Quantification of 15 Organic Impurities of Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide in Combined Dosage Form

Cited by 10 publications

References 25 publications

Response Surface Method for the Simultaneous Estimation of Atorvastatin and Olmesartan

Response Surface Method for the Simultaneous Estimation of Atorvastatin and Olmesartan

Simultaneous Evaluation of Amlodipine Besylate and Candesartan Cilexetil by Applying Chemometric Assisted Spectrophotometric Method

LC–MS/MS and in silico analysis of pharmaceutical impurities in a combination drug for hypertension

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