Development and Validation of Stability Indicating Rp-HPLC Method for Simultaneous Determination of Aspirin, Rosuvastatin, Clopidogrel in Bulk and Pharmaceutical Dosage Form

Pisal, Pooja; Nigade, Ganesh; Kale, Amol P; Pawar, Smita

doi:10.22159/ijpps.2018v10i10.28329

Cited by 12 publications

(6 citation statements)

References 8 publications

(4 reference statements)

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“…Chromatographic analysis for composed mixtures of ASA and antihypertensive, antiplatelet or antithrombotic agents, as well as CAF combined with some non-steroidal anti-inflammatory drugs (NSAIDs), have been developed by several authors [10][11][12]. Specifically, for ASA and CAF mixture in pharmaceutical formulations, spectrofluorometric [13] and electrochemical [3,14] determinations have been published.…”

Section: Fig 1: Molecular Structures Of Asa (Left) and Caf (Right)mentioning

confidence: 99%

Simultaneous Quantification of Acetylsalicylic Acid and Caffeine in Tablets by First-Order Derivative Spectroscopy

López

CONTRERAS-JIMENEZ²

2022

Int J App Pharm

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Objective: To develop an apply a new and easy UV-derivative method for the simultaneous quantification of acetylsalicylic acid (ASA) and caffeine (CAF) in commercial tablets. Derivative spectroscopy is an analytical methodology used to identify drugs in a mixture of two or more compounds without use of toxic dissolvents that are involved in chromatographic determinations. Methods: Standard solutions of ASA (40-120 µg/ml) and CAF (5-25 µg/ml) were prepared with 0.1 M phosphate buffer pH 7.4. The zero-order spectra were determined from 200-300 nm. The method was validated according to International Conference on Harmonization (ICH) guidelines. An USP Apparatus 2 at 75 rpm with 900 ml of 0.1 M phosphate buffer pH 7.4 was used. For each drug, common dissolution data as the amount of drug released at 60 min (Q60), mean dissolution time (MDT), dissolution efficiency (DE), t50% and t85% were calculated. Results: ASA was identified at 245 nm and CAF at 295 nm in the first-derivative mode. The method was linear (R2>0.99, *P<0.05). The precision and accuracy of the method were within acceptable limits. Q60, MDT, DE, t50%, and t85% values for ASA were 102.09%, 8.18 min, 88.15%, 2.91 min, and 11.98 min, respectively. Same parameters for CAF were 99.17%, 5.21 min, 90.54%, 1.09 min, and 5.70 min, respectively. Conclusion: The proposed UV-derivative method is rapid and simple and can be easily adopted to determine the in vitro release curves of ASA and CAF from commercial tablets. The method generates reliable information that can be compared with published data.

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Section: Fig 1: Molecular Structures Of Asa (Left) and Caf (Right)mentioning

confidence: 99%

Simultaneous Quantification of Acetylsalicylic Acid and Caffeine in Tablets by First-Order Derivative Spectroscopy

López

CONTRERAS-JIMENEZ²

2022

Int J App Pharm

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“…In this paper, we investigated the blood levels of this new compound with validated High Performance Liquid Chromatography UV method-Diode Array Detector (HPLC-DAD) [8,9]. This study aimed to describe the pharmacokinetic profile of 3CBB in rats following oral administration, as a part of its development as a new drug.…”

Section: Fig 1: Chemical Structure Of 3cbbmentioning

confidence: 99%

Characterization of Pharmacokinetics of 2-((3-(Chloromethyl)benzoyl)oxy) Benzoic Acid in Rats by Using HPLC-Dad Method

et al. 2019

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Objective: A new compound of salicylic acid derivative, namely 2-((3-(chloromethyl)benzoyl)oxy)benzoic acid (3CBB), was synthesized to find a compound exhibiting higher analgesic activity and smaller ulcer irritation than acetylsalicylic acid (ASA). Therefore, this study aimed to investigate the pharmacokinetics of this new compound in rats, following a single dose oral administration of 3CBB (45 mg/kg BW). Methods: Plasma samples of 9 healthy rats were collected before and up to 3 h after its oral administration, following an 18 h fasting period. Plasma concentrations of 3CBB were determined using a validated HPLC-DAD assay. Pharmacokinetic parameters were determined using the compartment model technique. All experiments were carried out in triplicate. Results: The pharmacokinetic parameters of 3CBB obtained were as follows: Tmax= 28.9±1.1 min, Cmax = 0.57±0.02 µg/ml, AUCtotal = 66.3±1.0 µg min/ml, Kel = 0.018±0.002 min-1, and T1/2el = 39.4±3.9 min. The long elimination half-life and low Cmax indicated that 3CBB was extensively distributed in the deep and very deep tissues. This confirmed the unique and special characteristics of a highly lipophilic compound like 3CBB (log P = 3.73). Conclusion: 3CBB demonstrated a slower onset of action and longer elimination time from the body compared to ASA. Thus this new compound is a potential candidate to be developed as a new drug.

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“…The enthalpy of interaction has an appositive value indicating that the formation of drug-Pb complex is endothermic [30]. The positive value of enthalpy and entropy change also refers to the type of interaction between drug and Pb ion which is electrostatic in nature [31].…”

Section: ∆H°=1305×8314=1084977 J/molmentioning

confidence: 99%

Thermodynamic and Kinetic Studies for the Binding of Lead Ion by Chelating With Theophylline 1,3-Dimethylxanthine (Therapy Drug)

Al-Ani¹

2019

Asian J Pharm Clin Res

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Objective: Chelating therapy is a medical procedure that involves the administration of chelating agents to remove heavy metals from the body; chelating agents detoxify heavy metals and toxins, converting them to inactive forms which were excreted out from the body. This work demonstrates the complication of the drug with toxic heavy metal lead (Π) ion. Methods: All the experiments were performed at different temperature (303, 308, 313, 318, and 323) °K, by spectrophotometric method. The electronic spectra of the mixture of drug and lead ion show a bathochromic (red) shift in ʎmax, the absorbance change caused by a complex arrangement between the lead ion and drug. Results: The stoichiometry of the complex formed was calculated using continuous variation method, it was found (1:2) that the durability constant was estimated that the standard thermodynamic parameters ΔH°, ΔG°, and ΔS° were determined, the negative values of free energy changes ΔG° indicate a spontaneous complexation process. The positive values of enthalpy change indicate an endothermic process with an increase in entropy change ΔS° (positive), that means the process in an entropy driven. Conclusion: The kinetic studies of the complexation of drug and ion were found to follow the second-order reaction, which was confined by the straight line and a high rate constant.

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Development and Validation of Stability Indicating Rp-HPLC Method for Simultaneous Determination of Aspirin, Rosuvastatin, Clopidogrel in Bulk and Pharmaceutical Dosage Form

Cited by 12 publications

References 8 publications

Simultaneous Quantification of Acetylsalicylic Acid and Caffeine in Tablets by First-Order Derivative Spectroscopy

Simultaneous Quantification of Acetylsalicylic Acid and Caffeine in Tablets by First-Order Derivative Spectroscopy

Characterization of Pharmacokinetics of 2-((3-(Chloromethyl)benzoyl)oxy) Benzoic Acid in Rats by Using HPLC-Dad Method

Thermodynamic and Kinetic Studies for the Binding of Lead Ion by Chelating With Theophylline 1,3-Dimethylxanthine (Therapy Drug)

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