Development and Validation of Stability Indicating Assay Method for Determination of Felodipine in Tablet Dosage Form

Patre, Narendra G.; Patil, Shivajirao R.

doi:10.25004/ijpsdr.2018.100409

Cited by 2 publications

(1 citation statement)

References 12 publications

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“…For the quantitative determination of felodipine in solid dosage form and in bulk, simple, precise, and sensitive HPTLC and RP-HPTLC methods have been developed and were validated as per ICH. These techniques can be used to analyse Felodipine in bulk and pharmaceutical preparations on a regular basis [21,22]. Table 2 represents the HPTLC methods for determining and estimating FDP in pharmaceuticals, formulations.…”

Section: Hptlcmentioning

confidence: 99%

Felodipine-Review of Analytical Methods Developed for Pharmaceutical Dosage Forms and Biological Fluids

MALLI,

KUMAR,

VERMA

2023

Int J App Pharm

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Felodipine (FDP) is a vascular selective L-type calcium channel blocker, in hypertension patients FDP significantly lowers systolic and diastolic blood pressure (BP). It is a lipophilic drug molecule that contains a dihydropyridine ring responsible to show pharmacological activity, it is mainly used to control and prevent essential hypertension. This review article provides a summary of various analytical techniques for determining felodipine in pure form, pharmaceutical formulations, and biological fluids. Various analytical techniques are developed and validated, such as ultraviolet/visible spectrophotometry, high-performance liquid chromatography (HPLC), high-performance thin layer chromatography (HPTLC), and bioanalytical techniques. Estimated validation parameters such as linearity, LOD (Limit of Detection), and LOQ (Limit of Quantification) are discussed for each method. The wavelength of detection (λmax), mobile phase, columns, flow rate, retention time (Rt) and sample preparation techniques are all important quality elements for calculating Felodipine via analytical procedures.

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Section: Hptlcmentioning

confidence: 99%

Felodipine-Review of Analytical Methods Developed for Pharmaceutical Dosage Forms and Biological Fluids

MALLI,

KUMAR,

VERMA

2023

Int J App Pharm

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Stability-Indicating UPLC-PDA-QDa Methodology for Carvedilol and Felodipine in Fixed-Dose Combinations Using AQbD Principles

Afonso Urich,

Marko,

Boehm

et al. 2024

Sci. Pharm.

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The development of analytical procedures, in line with the recent regulatory requirements ICH Q2 (R2) and ICH Q14, is progressing, and it must be able to manage the entire life cycle of the methodology. This is also applicable to and especially challenging for combinations of drug substances and dosage form. A reliable and efficient, stability-indicating, MS-compatible, reverse-phase ultra-performance liquid chromatographic (UPLC®) method was developed for the determination of carvedilol and felodipine in a combination oral dosage form. The development of the method, performed using analytical quality by design (AQbD) principles, was in line with the future regulatory requirements. Furthermore, the fixed-dose combination dosage forms are a clear solution to the polypharmacy phenomenon in the elderly population. The main factors evaluated were the mobile phase buffer, organic modifier, column, flow, and column temperature. The optimum conditions were achieved with a Waters Acquity HSS T3 (100 × 2.1 mm i.d., 1.8 µm) column at 38 °C, using ammonium acetate buffer (5 mM, pH 4.5) (Solution A) and MeOH (Solution B) as mobile phases in gradient elution (t = 0 min, 10% B; t = 1.5 min, 10% B; t = 12.0 min, 90% B; t = 13.0 min, 10% B; t = 15.5 min, 10% B) at a flow rate of 0.2 mL/min and UV Detection of 240 and 362 nm for carvedilol (CAV) and felodipine (FLP), respectively. The linearity was demonstrated over concentration ranges of 30–650 µg/mL (R2 = 0.9984) (CAV) and 32–260 µg/mL (R2 = 0.9996) (FLP). Forced degradation studies were performed by subjecting the samples to hydrolytic (acid and base), oxidative, and thermal stress conditions. Standard solution stability was also performed. The proposed validated method was successfully used for the quantitative analysis of bulk, stability, and fixed-dose combination dosage form samples of the desired drug product. Using the AQbD principles, it is possible to generate methodologies with improved knowledge, leading to high-quality data, lower operation costs, and minimum regulatory risk. Furthermore, this work paves the way for providing a platform of robust analytical methods for the simultaneous quantification of innovative on-demand new dose combinations.

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Development and Validation of Stability Indicating Assay Method for Determination of Felodipine in Tablet Dosage Form

Cited by 2 publications

References 12 publications

Felodipine-Review of Analytical Methods Developed for Pharmaceutical Dosage Forms and Biological Fluids

Felodipine-Review of Analytical Methods Developed for Pharmaceutical Dosage Forms and Biological Fluids

Stability-Indicating UPLC-PDA-QDa Methodology for Carvedilol and Felodipine in Fixed-Dose Combinations Using AQbD Principles

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