Spectrofluorometric estimation of aspirin and dipyridamole in pure admixtures and in dosage forms

Umapathi, P.; Parimoo, P.; Thomas, Simu K.; Agarwal, Vikas

doi:10.1016/s0731-7085(96)01918-8

Cited by 12 publications

(5 citation statements)

References 5 publications

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“…To determine active ingredients in any sample, suitable, simple, and accurate analytical methods are needed. The scientific community provides a wide variety of methods for the analysis of ACE (Ali et al, 2007; Bloomfield, 2002; Hewala, 1994; Kamberi et al, 2004; Kamyabi, 2009; Mohamed, 1997; Nemeth et al, 2008; Pérez‐Ruiz et al, 2005; Rao & Narasaraju, 2006; Wyszecka‐Kaszuba et al, 2003), ASP (Kokot & Burda, 1998; Kurbanoglu & Yarman, 2019; Umapathi et al, 1997), and CAF (Bruschettini et al, 2016; Charles et al, 2008; Marín & Barbas, 2004; Zhang et al, 2008).…”

Section: Introductionmentioning

confidence: 99%

An effective and stability‐indicating method development and optimization utilizing the Box–Behnken design for the simultaneous determination of acetaminophen, caffeine, and aspirin in tablet formulation

Yenda

Katari

Ettaboina³

et al. 2023

Biomedical Chromatography

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Analytical techniques must be sensitive, specific, and accurate to assess the active pharmaceutical ingredients in pharmaceutical dosage forms. The quality‐by‐design (QbD) application has proven to be a practical method for magnifying HPLC operations. This article discusses the successfully developed QbD‐based stability‐indicative LC method for evaluating acetaminophen, caffeine, and aspirin (ASP) in tablet dosage form. To achieve the necessary chromatographic separation, Milli‐Q water, methanol, and glacial acetic acid were employed in the following ratios: 63:35:2 (v/v/v) for mobile phase A and 18:80:2 (v/v/v) for mobile phase B. The flow rate, column temperature, and detecting wavelength were 1.0 ml/min, 40°C, and 275 nm, respectively, and an InertSustain C18 analytical column (150 × 4.6 mm, 3 μm) was used. Linearity was between 10.0 and 150.0 μg/ml for ASP and acetaminophen and between 2.6 and 39.0 μg/ml for caffeine. The accuracy findings were more than 97%, and the correlation coefficient for all three components was found to be greater than 0.999. The validated HPLC method yielded reliable and accurate results. ASP was shown to be vulnerable to both acid and alkaline hydrolysis in the forced degradation study. The described method is capable of separating the degradants produced during stress testing and is regarded as stability indicating. The proposed method can be used for a wider range of other formulations with an appropriate diluent selection and sample preparation procedure optimization.

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Section: Introductionmentioning

confidence: 99%

An effective and stability‐indicating method development and optimization utilizing the Box–Behnken design for the simultaneous determination of acetaminophen, caffeine, and aspirin in tablet formulation

Yenda

Katari

Ettaboina³

et al. 2023

Biomedical Chromatography

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“…A literature survey revealed several analytical methods, mostly for the estimation of ACE, ASP and CAF using different analytical techniques. The details of such reports are as follows: ACE (Ali, Rafiuddin, & Ghori, ; Bloomfield, ; Hewala, ; Kamberi, Riley, & Ma Sharon, ; Kamyabi, ; Mohamed, AbdAllah, & Shammat, ; Nemeth, Jankovics, & Nemeth‐Palotas, ; Perez‐Ruiz, Martinez‐Lozano, & Tomas, ; Rao & Narasaraju, ; Wysecka‐Kaszuba, Warowna‐Grzes'kiewicz, & Fijalek, ); ASP (Akay, Degim, & Sayal, ; Kokot & Burda, ; Umapathi, Parirqoo, & Thomas, ; McMahon & Kelly, ); and CAF (Bruschettini, Barco, & Romantsik, ; Charles, Townsend, & Steer, ; Marın & Barbas, ; Zhang, Mehrotra, & Budha, ). None of the reported methods were based on a stability‐indicating RP‐HPLC approach, for the estimation of all 14 cited impurities in the solid oral dosage forms.…”

Section: Introductionmentioning

confidence: 99%

Stability‐indicating HPLC method for simultaneous quantification of 14 impurities in excedrin tablet formulations and identification of new impurity by LC–MS in accelerated stability studies

Dongala

Katari

Palakurthi

et al. 2019

Biomedical Chromatography

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We developed novel stability-indicating HPLC method for simultaneous estimation of 14 impurities in excedrin tablet, a formulation with a combination of acetaminophen, aspirin, and caffeine. In addition, a new impurity that was generated through degradation of aspirin at high temperatures during the accelerated stability conditions was positively identified and confirmed, using liquid chromatography-mass spectrometry technique. The HPLC method was optimized using the Inertsustain C 18 , 250 × 4.6 mm, 5.0 μm column, employing simple gradient method. Forced degradation studies were performed under acidic, basic, oxidative and thermal conditions to prove the scope and stability-indicating the nature of the method. The optimized method was validated as per the International Conference on Harmonization guidelines. The HPLC method showed linearity from LOQ concentration to 21 μg mL −1 . Precision and intermediate precision values were <5% RSD. The validated HPLC method is currently applied for the routine testing of excedrin tablet formulations in quality control laboratories.

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“…A number of analytical methods have been reported in the literature for the individual determination of CLP or ASA. These methods include: spectrofluorimetry [5], reversed phase liquid chromatography (LC) [6][7][8][9], thin-layer chromatography [10], and spectrophotometry [11,12]. The simultaneous assay determination of CLP and ASA in tablets and capsules was also reported [13,14].…”

Section: Introductionmentioning

confidence: 99%

Development and validation of a liquid chromatographic method for purity control of clopidogrel–acetylsalicylic acid in combined oral dosage forms

Kahsay

Schepdael

Adams

2012

Journal of Pharmaceutical and Biomedical Analysis

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A reversed phase liquid chromatographic method with UV detection for the simultaneous determination of clopidogrel and acetylsalicylic acid and their related substances in combined oral formulations was developed and validated. Good separation was achieved on a Luna C18 column (150 mm × 4.6 mm, 3 μm) using gradient elution at a flow rate of 1 mL/min and a column temperature of 35 °C. UV detection was performed at 220 nm. The validation was performed according to the ICH guidelines. The method proved to be specific, sensitive (LOQ=0.975 μg/mL and 0.0384 μg/mL for clopidogrel and acetylsalicylic acid, respectively), linear in the concentration range from LOQ to 325 μg/mL for clopidogrel and from LOQ to 650 μg/mL for acetylsalicylic acid, precise (RSD values for intermediate precision <1%) and accurate with mean recovery values of 100.7% and 100.2% for clopidogrel and acetylsalicylic acid, respectively. Moreover, the solution stability and method robustness were examined. The method gives satisfactory separation of impurities of clopidogrel and acetylsalicylic acid and so it is suitable for quantification of the related substances as well as for the assay of the actives.

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Spectrofluorometric estimation of aspirin and dipyridamole in pure admixtures and in dosage forms

Cited by 12 publications

References 5 publications

An effective and stability‐indicating method development and optimization utilizing the Box–Behnken design for the simultaneous determination of acetaminophen, caffeine, and aspirin in tablet formulation

An effective and stability‐indicating method development and optimization utilizing the Box–Behnken design for the simultaneous determination of acetaminophen, caffeine, and aspirin in tablet formulation

Stability‐indicating HPLC method for simultaneous quantification of 14 impurities in excedrin tablet formulations and identification of new impurity by LC–MS in accelerated stability studies

Development and validation of a liquid chromatographic method for purity control of clopidogrel–acetylsalicylic acid in combined oral dosage forms

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