A pragmatic approach to the analysis of a combination formulation

Mubtasim, Noshin; Kabir, Eva Rahman; Podder, Ashis Kumar; Bhadra, Subrata

doi:10.1016/j.jsps.2015.06.004

Cited by 13 publications

(7 citation statements)

References 4 publications

(5 reference statements)

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“…Therefore, it is a relatively rapid and inexpensive technique to predict the in-vivo performance of pharmaceutical dosage forms. 34 Hence, it will promote interchangeability of the products, will ensure the same pharmacological effect and the lower cost will be a benefit to the patient.…”

Section: Resultsmentioning

confidence: 99%

<p>In vitro Comparative Quality Assessment of Different Brands of Furosemide Tablets Marketed in Northwest Ethiopia</p>

Abebe¹,

Ketema²,

Kassahun³

2020

DDDT

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Background: The use of ineffective and poor quality drugs endangers therapeutic treatment and may lead to treatment failure. For desired therapeutic effect, drugs should contain the appropriate amount of active pharmaceutical ingredient and the required physical characteristics. Aim: The aim of this study was to evaluate quality as well as physicochemical bioequivalence of different brands of furosemide tablets marketed in Bahir Dar, Northwest Ethiopia. Methods: Five different brands of furosemide tablets were purchased from community pharmacies in Bahir Dar city, Northwest Ethiopia. The quality control parameters of furosemide tablets were determined by identification, weight variation, disintegration, assay and dissolution tests and the results were compared with USP and BP pharmacopoeial standards. Difference (f1) and similarity (f2) factors were calculated to assess in vitro bioequivalence requirements. Results: Identification test results revealed that all samples contained the stated active pharmaceutical ingredients. The results of weight variation tests indicated that all samples complied with USP specification limits. The active pharmaceutical ingredients quantitative assay showed that all the brands of furosemide tablets were between the 90% and 105% limit of label claim. Similarly, all samples fulfilled disintegration time (i.e., ≤30 min) and dissolution tolerance limits (i.e., Q ≥80% at 60 min). Hence, none of the samples were found to be counterfeit and/or substandard. Difference factor (f1) values were <15 and similarity factor (f2) values were >50 for all the tested brands of furosemide tablets. Conclusion: This study revealed that all the furosemide brands met the quality specification of weight variation, hardness, friability, dissolution, disintegration and assay. The study also indicated similarity in the dissolution profile of the brands of furosemide tablets with the innovator product. Hence, all of these generic brands could be substituted with the innovator product in clinical practice.

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Section: Resultsmentioning

confidence: 99%

<p>In vitro Comparative Quality Assessment of Different Brands of Furosemide Tablets Marketed in Northwest Ethiopia</p>

Abebe¹,

Ketema²,

Kassahun³

2020

DDDT

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“…A characteristic peak at 1101 cm -1 was caused by S=O stretching in besylate. 23 TD Bat 1-11 had both peaks due to the intrinsic peaks of TD, C=C aromatic and C=O. AM Bat 1-6 was also confirmed to have C=O stretching peak, which is the characteristic peak of AM.…”

Section: Resultsmentioning

confidence: 82%

Formulation of Double-layer Tadalafil and Amlodipine Complex Tablets to Treat Erectile Dysfunction and Hypertension

신은영¹,

박종호²,

신명은³

et al. 2019

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Many men over the age of 40 suffer from erectile dysfunction (ED) for a variety of reasons. In addition, more than 40% of ED patients have hypertensive disease at the same time. Tadalafil (TD) is a selective and reversible inhibitor of cyclic guanosine monophosphate-specific phosphodiesterase type 5 (cGMP-specific PDE-5). It is an insoluble drug with biopharmaceutics classification system class-II and was prepared by wet granulation with a solubilizing agent. Amlodipine besylate (AM) is a calcium channel antagonist that is effective in preventing systolic hypertension and stroke, and is manufactured using physical mix method. We used TD and AM to fabricate a double-layer complex tablet that can prevent or treat two diseases at the same time. Scanning electron microscope (SEM), Fourier-transform infrared spectroscopy (FTIR), differential scanning calorimeter (DSC), X-ray diffraction (XRD) were analyzed for confirming chemical and physical characterization. Also, in vitro dissolution test was conducted to evaluate the dissolution rate of tablet at pH=1.2. In conclusion, the rapid release of two drugs in the double layer tablet was confirmed and could be applied as a pharmaceutical therapeutic agent.

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“…The final reaction product was confirmed by IR [26] where the spectrum of pure ALD showed two peaks at 3301 and 3156 cm corresponding to primary amino group and two characteristic peaks at 1695 and 1677 cm to presence of two carbonyl groups of ester linkage; Fig. 5a, while IR spectrum of final reaction product showed disappearance of primary amine peaks indicating that aldehyde group of anisaldehde reacted with primary amine of ALD-B and formation of Schiff base which also showed disappearance of two peaks of two C=O of ester linkage in ALD-B; Fig.…”

Section: Stoichiometry Of the Reactionmentioning

confidence: 99%

Determination of Amlodipine Besilate and Azilsartan Medoxomil by UHPLC, HPTLC and Spectrophotometric Techniques

Soliman

Darwish

Abdel-Razeq

2019

IRJPAC

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Aims: To develop methods with complete validation according to ICH guidelines and to be applied for the determination of both drugs in laboratory prepared mixtures and in synthetic tablets. Study Design: Ultra high performance liquid chromatography (UHPLC), High performance thin layer chromatography (HPTLC) and visible spectrophotometric methods are developed for determination of amlodipine besilate and azilsartan medoxomil in laboratory-prepared mixtures and in synthetic tablets. Methodology: Two techniques have been developed for the simultaneous determination of amlodipine besilate and azilsartan medoxomil in pure form and synthetic tablets. The first was UHPLC in which separation was achieved on a C18 column using 0.1% o-phosphoric acid - acetonitrile - methanol (60:10:30, by volume) as mobile phase with detection at 243nm. The second was HPTLC where separation was performed on silica gel 60 F254 plates using chloroform- tolune-methanol-glacial acetic acid (7: 1.5: 1.5: 0.5 by volume) as a developing system and UV detection at 243nm. In addition, visible- spectrophotometric method was developed for determination of amlodipine besilate in presence of azilsartan medoxomil through formation of yellowish orange colored product after reaction of amlodipine besilate with anisaldehde in acid medium with λmax at 443 nm. Results: UHPLC method was linear over the concentration ranges of 2-20 μg/ mL and 4-40 μg/ mL while HPTLC method was linear over the concentration ranges of 0.2 -4.0 μg/ spot and 0.5-8.0 μg/ spot for amlodipine besilate and azilsartan medoxomil, respectively. The visible spectrophotometric method was found to be valid over the concentration range of 10–80 μg/mL for amlodipine besilate. Conclusion: The proposed three techniques are rapid, accurate and precise, thus can be effectively applied for the routine estimation of both drugs in bulk and in their combined formulations.

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A pragmatic approach to the analysis of a combination formulation

Cited by 13 publications

References 4 publications

<p>In vitro Comparative Quality Assessment of Different Brands of Furosemide Tablets Marketed in Northwest Ethiopia</p>

<p>In vitro Comparative Quality Assessment of Different Brands of Furosemide Tablets Marketed in Northwest Ethiopia</p>

Formulation of Double-layer Tadalafil and Amlodipine Complex Tablets to Treat Erectile Dysfunction and Hypertension

Determination of Amlodipine Besilate and Azilsartan Medoxomil by UHPLC, HPTLC and Spectrophotometric Techniques

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