Stability Indicating HPTLC Method for Simultaneous Determination of Amlodipine Besylate and Lisinopril in Combined Dose Tablet Formulation

Wankhede, Sagar B.; Khobragade, Deepak S.; Lote, Sukeshini; Patil, Shivajirao R.

doi:10.52711/0974-360x.2021.01081

Cited by 2 publications

(1 citation statement)

References 23 publications

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“…It prevents coronary arterial contraction and narrowing of the arteries, leading to increased blood flow and myocardial oxygenation [7]. Pharmaceutical formulations with the combination of amlodipine as a calcium channel blocker channel blocker and lisinopril as a long-acting ACE inhibitor have been made available on the market to treat hypertension [8].…”

Section: Introductionmentioning

confidence: 99%

Simultaneous determination of amlodipine and lisinopril dihydrate using fourth derivative spectroscopy

Nejres

Najem

2023

Eur J Chem

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A new fast and simple selective method for the simultaneous determination of lisinopril dihydrate and amlodipine in combined drugs was developed using the fourth derivative spectrum method, based on the zero-crossing-point technique for the determination of compounds in drugs. The wavelength values for lisinopril dihydrate and amlodipine in solvent medium were found to be (203, 207, and 231 nm) and (215, 254, and 277 nm), respectively, with the average obeying Beer’s law in the range of lisinopril dihydrate 2.0 to 45.0 µg/mL and amlodipine 2.0 to 35.0 µg/mL. Lisinopril dihydrate has molar absorptivity regions (9227.76-11700.28 L/mol.cm, 203 nm), (15320.74-20795.59 L/mol.cm, 207 nm), and (2207.60-3311.40 L/mol.cm, 231 nm), while amlodipine (5886.72-10914.96 L/mol.cm, 215 nm), (5518.8-6418.16 L/mol.cm, 254 nm) and (1676.08-1921.36 L/mol.cm, 277 nm). The recovery rate of lisinopril dihydrate in the pharmaceutical dosage forms range was 95.13 to 102.60% and amlodipine 95.14 to 102.80%. The results of the relative error showed that the interferences did not affect the method of estimating these compounds. The proposed method has been successfully applied to estimate pharmaceutical dosage forms.

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Section: Introductionmentioning

confidence: 99%

Simultaneous determination of amlodipine and lisinopril dihydrate using fourth derivative spectroscopy

Nejres

Najem

2023

Eur J Chem

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Characterization of famotidine API and simultaneous Quantification of its organic impurities by UPLC

Reddy

Shyamala

Krishna

et al. 2023

RJPT

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To evaluate the characterization of Famotidine API (active pharmaceutical ingredient) and develop the accurate, precise, linear ultra-performance liquid chromatographic (UPLC) method for quantitating determination of organic impurities (Impurity-A, Impurity-B, and Impurity-C) in Famotidine API, pharmaceutical dosage forms and the method has been validated as per international council of harmonization (ICH) guidelines. The Famotidine API characterization was done by using spectroscopic techniques such as mass, infrared spectroscopy (IR), differential scanning calorimetry (DSC), proton nuclear magnetic resonance (1H-NMR), Carbon-13 nuclear magnetic resonance (C13-NMR), and two-dimensional nuclear magnetic resonance (2D-NMR). The organic impurities (A, B, and C) quantification was done using ACQUITY UPLC CSH C18- 100 mm × 2.1 mm, 1.7 μm column connected to ACQUITY UPLC with PDA detector. The optimized chromatographic conditions were achieved at 0.3 mL/min flow rate using a gradient system with 0.1% Tri fluoro acetic acid in water acetonitrile and Methanol as mobile phase. Three organic impurities are measured at λmax 260 nm at 45°C column temperature. Famotidine structure was confirmed by the appraised complete characterization data. The coefficient of correlation (r2) for the Impurity-A, Impurity-B, and Impurity-C was obtained not less than 0.99. The limit of detection (LOD) obtained 0.12 µg/mL and the limit of quantification (LOQ) obtained 0.4 µg/mL for each impurity concerning Famotidine test concentration. The method was fully validated as precision, accuracy, LOQ precision, LOQ accuracy, ruggedness, and robustness complying with FDA, ICH, AOAC, and European medicines agency (EMEA) guidelines. The characterization study and the proposed UPLC method were specific, accurate, precise, linear, rugged, and robust for the determination of the three organic impurities in Famotidine API and it can be implemented for its intended use in pharmaceutical industries.

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Stability Indicating HPTLC Method for Simultaneous Determination of Amlodipine Besylate and Lisinopril in Combined Dose Tablet Formulation

Cited by 2 publications

References 23 publications

Simultaneous determination of amlodipine and lisinopril dihydrate using fourth derivative spectroscopy

Simultaneous determination of amlodipine and lisinopril dihydrate using fourth derivative spectroscopy

Characterization of famotidine API and simultaneous Quantification of its organic impurities by UPLC

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