"HPLC-UV method approach for the analysis and impurity profiling of Captopril "

Cârje, Anca Gabriela; Balint, Alina; Ion, Valentin; Pop, Anca; Muntean, Daniela-Lucia; Sabău, Raluca; Imre, Silvia

doi:10.24193/subbchem.2019.2.19

Cited by 4 publications

(3 citation statements)

References 8 publications

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“…According to the USP edition in force requirements, the determination of lipoic alpha acid in tablets was carried out by an HPLC method [81,82]. The relative SD for repeated injections of the standard solution was not more than 2.0%; the reagents used were: Bidistilled water; Acetonitrile; Potassium phosphate; Methanol; Phosphoric acid solution [83,84]. Reference substances: Alpha-lipoic acid (Azienda Chimica e Farmaceutica, Italy).…”

Section: Methodsmentioning

confidence: 99%

Evaluation of Dissolution Profiles of a Newly Developed Solid Oral Immediate-Release Formula Containing Alpha-Lipoic Acid

Pop

Crișan²,

Barca

et al. 2021

Processes

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Alpha-lipoic acid (ALA, thioctic acid), a naturally-occurring essential dithiol compound, has become a common ingredient in many pharmaceutical and food supplement products (FSP), used in oxidative stress-dependent pathologies; oral bioavailability of ALA is limited by pharmacokinetic particularities that reduce its therapeutic efficacy-reduced solubility, lack of gastric stability and hepatic degradation, doubled by formulation hinders. The objectives were to develop a solid oral 600 mg ALA FSP to obtain an optimal pharmaceutical profile compared to a reference listed drug (RLD) with a similarity factor f2 50. A comparative dissolution study was performed; an HPLC method was used for ALA quantification. After planning combinatory simulations (formulation stage), two prototype formulas (#1 and #2) were manufactured and further optimized by adjusting ALA physical characteristics and the excipients quantities (#3 and #4) in order to achieve the Quality Target Product Profile. A misshapen of ALA’s in vitro release was observed for #3 Formula (f2 = 31.6); the optimal profile was obtained for Formula #4 (f2 = 58.5). A simple quantitative formula is not enough to assure good ALA bioavailability; the formulation needs multiple compounding modulations under physicochemical compatibility algorithms, with multiple dissolution profiles testing back-ups. It is essential to ensure a formulation with an in vitro dissolution comparable with the RLD, allowing the compound to reach its target level to assure the optimum claimed antioxidant activity of ALA at the cellular level, even for food supplement formulations.

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Section: Methodsmentioning

confidence: 99%

Evaluation of Dissolution Profiles of a Newly Developed Solid Oral Immediate-Release Formula Containing Alpha-Lipoic Acid

Pop

Crișan²,

Barca

et al. 2021

Processes

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“…Injection volume was 10 µL, and a C18 chromatographic column (150 mm length x 4.6 mm i.d.) used 5 µm particle size was used [26]. The system suitability was tested.…”

Section: Hesperidin Assaymentioning

confidence: 99%

Study Regarding a New Extended-Release Calcium Ascorbate and Hesperidin Solid Oral Formulation

Pop¹

2022

FARMACIA

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Vitamin C is indispensable for the normal functioning of the most important biological processes in the human body and plays an essential role in the immune response to stress and viral and bacterial infections. Hesperidin is a bioflavonoid with vascularprotecting and anti-inflammatory properties. Given the benefits of vitamin C and hesperidin and the increased absorption of vitamin C by bioflavonoids, a dietary supplement containing both active ingredients has been developed to improve the functioning of the human immune system. Calcium ascorbate was used for vitamin C intake to reduce the high acid side effects at the gastric level. A slow-release pharmaceutical formulation was chosen to gradually release the active ingredients and a prolonged effect (prolonged-release tablets). The present study presents the quality analysis of this innovative dietary supplement with a formula based on non-acidic vitamin C (containing 605 mg of calcium ascorbate, equivalent to 500 mg of ascorbic acid) and bitter orange (Citrus aurantium) bioflavonoid complex (standardised to 80% hesperidin) by testing the following parameters: the neutrality of the product, the vitamin C assay, the hesperidin assay, and in vitro vitamin C dissolution. The study revealed suitable active substances contents of the product and a delayed pharmaceutical formulation that extends the duration of beneficial effects on the human body with reduced side effects. RezumatVitamina C este indispensabilă pentru desfășurarea normală a celor mai importante procese biologice și joacă un rol esențial în modularea răspunsului imun la stres și la infecțiile virale și bacteriene. Hesperidina este un bioflavonoid cu proprietăți vasculoprotectoare și antiinflamatoare. Având în vedere beneficiile vitaminei C și ale hesperidinei, precum și creșterea absorbției vitaminei C în prezența bioflavonoidelor, a fost dezvoltat un supliment alimentar pentru îmbunătățirea funcționării sistemului imunitar, care conține ambele ingrediente active. Pentru aportul de vitamina C a fost utilizat ascorbat de calciu pentru a reduce efectele secundare de hiperaciditate gastrică. A fost aleasă o formulare farmaceutică cu cedare prelungită pentru a asigura o eliberare treptată a ingredientelor active și un efect prelungit (comprimate cu eliberare prelungită). Prezentul studiu prezintă controlul calității acestui supliment alimentar inovator cu o formulă bazată pe vitamina C neacidă (605 mg de ascorbat de calciu, echivalent cu 500 mg de acid ascorbic) și un complex bioflavonoid din portocală amară (Citrus aurantium) (standardizat la 80% hesperidină), prin testarea următorilor parametri: neutralitatea produsului, dozarea vitaminei C, dozarea hesperidinei și dizolvarea in vitro a vitaminei C. Studiul a demonstrat conținutul adecvat de substanțe active al produsului și formularea farmaceutică care oferă o prelungire a duratei efectelor benefice asupra organismului uman, cu efecte secundare reduse.

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“…For this reason, CAP as an antihypertension drug should be analyzed carefully because it is frequently used in the treatment of diseases and because of its negative effects on the human body. Looking at the research in the literature, it is clear that several traditional approaches have been successfully used to identify the presence of CAP in pharmaceutical products and human fluid samples including spectrophotometric [7], Raman spectroscopy [8], capillary electrophoresis [9], electrochemical [10][11][12][13], high-performance liquid chromatography (HPLC) [14][15][16][17][18]. HPLC is the most widely utilized method in the pharmaceutical industry for the manufacturing, development, and analysis of pharmaceuticals, particularly in quality control laboratories, as can be shown from literature studies.…”

Section: Introductionmentioning

confidence: 99%

Green Procedure Index Assessment of the Novel Stability-Indicating Rp-HPLC Method for the Determination of Captopril From Pharmaceutical Dosage Form

Erkmen

Uslu

2023

Ankara Ecz. Fak. Derg.

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Objective: In this study, it was aimed to develop a novel reverse-phase liquid chromatography method for the ultra-sensitive determination of the antihypertensive drug captopril, using paracetamol, which is the common pain killer, as the internal standard. Optimization of all experimental conditions including composition of mobile phase, flow rate, and column temperature was carried out step by step, and the method validity of the developed method was examined according to international validation guidelines. Calibration range, linearity, the limit of determination, the limit of quantification, robustness, accuracy from commercial tablet samples, and method stability were examined in detail. In addition, the greenness profile for the developed method was assessed with the Green Analytical Procedure Index and Analytical Greenness Calculator techniques, which are frequently used in the literature. Material and Method: The chromatographic method was conducted with an XBridge C18 column (25 cm x 4.6 mm ID; 5 µm) packed with fully porous silica materials. All analyses were performed isocratically with a mobile phase containing acetonitrile:5 mM, pH 7.0 ammonium acetate solution (50:50, v/v) at a flow rate of 1.5 ml min-1. The injection volume was 5 μl, and the column was kept at 25°C in a column oven. The column eluate was monitored at 220 nm. Under optimized conditions, retention times of captopril, and paracetamol were approximately 1.59, and 2.0 min, respectively. Result and Discussion: This study described a fully validated, simple, sensitive, accurate, linear, precise, and reproducible reversed-phase liquid chromatography method for the determination of captopril in tablet samples. Under optimal experimental conditions, the linear range was found in the range of 0.5-200 µg ml-1 and the correlation coefficient was greater than 0.99. Method precision was acceptable, with coefficients of variation between 0.05% and 0.61%. In addition, as a result of the recovery studies carried out on the tablet samples, the accuracy was found to be within satisfactory limits between 99.45% and 102.55%. Moreover, the greenness profile of the developed method also showed that the method is environmentally friendly.

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"HPLC-UV method approach for the analysis and impurity profiling of Captopril "

Cited by 4 publications

References 8 publications

Evaluation of Dissolution Profiles of a Newly Developed Solid Oral Immediate-Release Formula Containing Alpha-Lipoic Acid

Evaluation of Dissolution Profiles of a Newly Developed Solid Oral Immediate-Release Formula Containing Alpha-Lipoic Acid

Study Regarding a New Extended-Release Calcium Ascorbate and Hesperidin Solid Oral Formulation

Green Procedure Index Assessment of the Novel Stability-Indicating Rp-HPLC Method for the Determination of Captopril From Pharmaceutical Dosage Form

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