Development and Validation of Fast, Simple, Cost-effective and Robust RP-HPLC Method for Simultaneous Determination of Lisinopril and Amlodipine in Tablets

Piponski, Marjan; Stoimenova, Tanja Bakovska; Serafimovska, Gordana Trendovska; Стефова, Марина

doi:10.1080/22297928.2019.1650108

Cited by 5 publications

(5 citation statements)

References 20 publications

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“…39 The difference in pK a between AML (pK a = 8.6) and TMS (pK a = 4.4) was 4.2, which was a sufficient difference in pK a to form ionic interactions between them. 40,41 These results suggested the formation of a co-amorphous salt via ionic interactions between TMS and AML at a 1:1 molar ratio.…”

Section: ■ Results and Discussionmentioning

confidence: 81%

“…In addition, salt formation via ionic interactions between acids and bases is generally feasible for mixtures with a difference in p K a > 4 . The difference in p K a between AML (p K a = 8.6) and TMS (p K a = 4.4) was 4.2, which was a sufficient difference in p K a to form ionic interactions between them. , These results suggested the formation of a co-amorphous salt via ionic interactions between TMS and AML at a 1:1 molar ratio.…”

Section: Resultsmentioning

confidence: 82%

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Designing a Novel Coamorphous Salt Formulation of Telmisartan with Amlodipine to Enhance Permeability and Oral Absorption

et al. 2023

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Coamorphous formulation is a useful approach for enhancing the solubility of poorly water-soluble drugs via intermolecular interactions. In this study, a hydrogen-bondingbased coamorphous system was developed to improve drug solubility, but it barely changed the apparent permeability (P app ) of the drug. This study aimed to design a novel coamorphous salt using ionic interactions to improve drug permeability and absorption. Telmisartan (TMS), with an acidic group, was used to form a coamorphous salt with basic amlodipine (AML). Evaluation of the physicochemical properties confirmed the formation of a coamorphous salt via ionic interactions between the amine group of AML and the carboxyl group of TMS at a molar ratio of 1:1. The coamorphous salt of TMS/AML enhanced the partitioning of both drugs into octanol, indicating increased lipophilicity owing to the interaction between TMS and AML. The coamorphous salt dramatically enhanced TMS solubility (99.8 times that of untreated TMS) and decreased AML solubility owing to the interaction between TMS and AML. Although the coamorphous salt showed a decreased P app in the permeation study in the presence of a thicker unstirred water layer (UWL) without stirring, P app increased in the presence of a thinner UWL with stirring. The oral absorption of TMS from the coamorphous salt increased by up to 4.1 times compared to that of untreated TMS, whereas that of AML remained unchanged. Although the coamorphous salt with increased lipophilicity has a disadvantage in terms of diffusion through the UWL, the UWL is thin in human/animal bodies owing to the peristaltic action of the digestive tract. Dissociation of the coamorphous salt on the membrane surface could contribute to the partitioning of the neutral form of drugs to the membrane cells compared with untreated drugs. As a result, coamorphous salt formation has the advantage of improving the membrane permeation and oral absorption of TMS, owing to the enhanced solubility and supply of membrane-permeable free TMS on the surface of the membrane.

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Section: ■ Results and Discussionmentioning

confidence: 81%

Section: Resultsmentioning

confidence: 82%

Designing a Novel Coamorphous Salt Formulation of Telmisartan with Amlodipine to Enhance Permeability and Oral Absorption

et al. 2023

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“…This method could be very useful for fast high‐throughput analysis if the first peak was not eluting very close to the void volume of the column, leading to the possibility for co‐elution with a peak of some other ingredient that might appear. We used this column, mobile phase composition, and experimental parameters because we had a previous positive experience when used for lisinopril and amlodipine quantification in combined solid pharmaceutical dosage forms [33]. A short highly retentive column with small dimensions confirmed our suspects for an excessive resolution between peaks.…”

Section: Resultsmentioning

confidence: 99%

Chaotropic salts impact in HPLC approaches for simultaneous analysis of hydrophilic and lipophilic drugs

Shulyak

Piponski²,

Коваленко

et al. 2021

J of Separation Science

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Simultaneous determination of drugs with different physicochemical properties necessitates thorough research and careful selection of high‐performance liquid chromatography conditions. In the present study, various concepts of high‐performance liquid chromatography method development for this aim have been discussed. Moreover, the work was motivated by the advantages of utilizing different chaotropic anions as a new promising approach to overcome the limitations of ion‐pairing agents commonly used for this purpose. Based on log P values, atorvastatin (log P = 6.36) and lisinopril (log P = –1.22) were chosen as representative examples for lipophilic and hydrophilic drugs, respectively. Several simple, economic, fast, and reliable high‐performance liquid chromatography methods were developed for their simultaneous analysis and are presented in a comparative manner, highlighting their advantages and limitations. Peak elution profile showed satisfying retentions and resolution about 3. Photo‐diode array calculations were exploited for identifying the molecules by their ultra‐violet spectra and peak purity, calculated and presented as rectangular‐shaped ratio grams. The linearity check showed excellent results and satisfactory system suitability parameters of both peaks. This confirms the investigation results and conclusions for the influence of the chaotropic salts on N‐containing molecules, by increasing their retentivities, and improving peak shapes, even on different quality columns without end‐capping and base‐deactivating of separation matrixes.

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“…To separate and then determine the components of combination drugs, high- and ultrahigh-performance liquid chromatography (LC) [ 4 , 5 , 6 , 7 , 8 ], microemulsion LC [ 9 ], hydrophilic interaction LC [ 10 ], and capillary electrophoresis [ 11 , 12 ] are used. The preliminary separation of active components makes the analysis difficult, time-consuming, expensive, and often polluting.…”

Section: Introductionmentioning

confidence: 99%

Perfluorosulfonic Acid Membranes Modified with Polyaniline and Hydrothermally Treated for Potentiometric Sensor Arrays for the Analysis of Combination Drugs

et al. 2023

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A novel potentiometric multisensory system for the analysis of sulfamethoxazole and trimethoprim combination drugs was developed. The potentiometric sensors (Donnan potential (DP) was used as an analytical signal) with an inner reference solution were based on perfluorosulfonic acid (PFSA) membranes modified with polyaniline (PANI) by in situ oxidative polymerization. The order of the membrane treatment with precursor solutions and their concentrations was varied. Additionally, the PFSA/PANI composite membranes were hydrothermally treated at 120 °C. The influence of the preparation conditions and the composition of membranes on their sorption and transport properties was studied. We estimated the factors affecting the sensitivity of DP-sensors based on the PFSA/PANI composite membranes to ions of sulfamethoxazole and trimethoprim simultaneously presented in solutions. A developed multisensory system provided a simultaneous determination of two analytes in aqueous solutions without preliminary separation, derivatization, or probe treatment. The re-estimation of the calibration characteristics of the multisensory system did not show a statistically significant difference after a year of its use. The limits of detection of sulfamethoxazole and trimethoprim were 1.4 × 10−6 and 8.5 × 10−8 M, while the relative errors of their determination in the combination drug were 4 and 5% (at 5 and 6% relative standard deviation), respectively.

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Development and Validation of Fast, Simple, Cost-effective and Robust RP-HPLC Method for Simultaneous Determination of Lisinopril and Amlodipine in Tablets

Cited by 5 publications

References 20 publications

Designing a Novel Coamorphous Salt Formulation of Telmisartan with Amlodipine to Enhance Permeability and Oral Absorption

Designing a Novel Coamorphous Salt Formulation of Telmisartan with Amlodipine to Enhance Permeability and Oral Absorption

Chaotropic salts impact in HPLC approaches for simultaneous analysis of hydrophilic and lipophilic drugs

Perfluorosulfonic Acid Membranes Modified with Polyaniline and Hydrothermally Treated for Potentiometric Sensor Arrays for the Analysis of Combination Drugs

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