Application of a Validated Stability-Indicating HPTLC Method for Simultaneous Estimation of Paracetamol and Aceclofenac and their Impurities

Ambekar, Archana; Bs, Kuchekar

doi:10.4172/2157-7064.1000324

Cited by 7 publications

(4 citation statements)

References 15 publications

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“…No Spectrophotometric methods have been previously studied for the concurrent determination of the cited drugs in the occurrence of their degradation products. While, literature survey revealed their stability study viz HPTLC [36], HPLC [37, 38] and UPLC [39]. But unfortunately, these stated methods were limited for mixtures containing minute amount of degradation products.…”

Section: Introductionmentioning

confidence: 99%

Study of efficiency and spectral resolution for mathematical filtration technique using novel unlimited derivative ratio and classical univariate spectrophotometric methods for the multicomponent determination-stability analysis

Lotfy

Ahmed

El-Rahman

et al. 2019

Heliyon

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Six simple, sensitive and selective spectrophotometric methods based on mathematical filtration technique are presented for concurrent determination of aceclofenac (ACE) and paracetamol (PAR) in presence of their degradation products, namely; diclofenac sodium (DIC) and 4-aminophenol (4-AP), respectively without preliminary physical separation procedures. This technique consists of several consecutive steps applied on built-in spectrophotometer software utilizing zero and/or derivative and/or ratio spectra of the studied components. These methods, namely, dual wavelength (DW), induced dual wavelength (IDW), derivative subtraction (DS) coupled with constant multiplication (CM), ratio difference method (RD), constant center method (CC) and the novel introduced unlimited derivative ratio method (UDD). This novel method has a very powerful competence for the analysis of the challengeable mixtures lacking zero crossing point. The linearity, accuracy and precision ranges of these methods were determined and validated as per ICH guidelines. Moreover, the specificity was checked by analyzing synthetic mixtures of both drugs. These methods were applied for the determination of the cited drugs in pharmaceutical formulation and a statistical comparison of the obtained results was made with each other and with those of reported spectrophotometric method. The comparison of the results of pure powder form showed that there is no significant difference between the proposed methods and the reported method regarding both accuracy and precision.

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Section: Introductionmentioning

confidence: 99%

Study of efficiency and spectral resolution for mathematical filtration technique using novel unlimited derivative ratio and classical univariate spectrophotometric methods for the multicomponent determination-stability analysis

Lotfy

Ahmed

El-Rahman

et al. 2019

Heliyon

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“…Paracetamol is official in the British pharmacopoeia (BP) [3]. Literature survey has revealed that PAR in its single form or combined with other drugs was determined by titrimetry [3, 4], spectrophotometry [5–7], spectrofluorimetry [8], high performance thin layer chromatography (HPTLC) [9, 10] GC–MS [11], HPLC–UV [11–13], HPLC–MS/MS [14] and micellar electrokinetic capillary chromatography (MECC) [15]. PSE; [(+)-threo-a-[1-methylamino) ethyl] benzyl alcohol] hydrochloride, is a sympathomimetic amine that acts on adrenergic receptors directly.…”

Section: Introductionmentioning

confidence: 99%

Analytical methods for the determination of paracetamol, pseudoephedrine and brompheniramine in Comtrex tablets

et al. 2019

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Comtrex ® tablets composed of paracetamol, pseudoephedrine and brompheniramine are widely used for relieving symptoms related to common cold. This study has overcome the challenging dosage form ratio (250:15:1) and proposed chromatographic methods for analyzing the ternary combination were utilized displaying different apparatus, solvents and sensitivity ranges. Three chromatographic methods namely thin layer chromatography (TLC), high performance liquid chromatography with ultra-violet detection (HPLC–UV) and ultra-performance liquid chromatography coupled to tandem mass spectrometry (UPLC-MS/MS) were developed and validated for the simultaneous determination of the three drugs. Concerning the TLC method, aluminum TLC plates pre-coated with silica gel 60F 254 were used and methanol:water:ammonia (9:1:0.1, v/v/v) was applied as a mobile phase; scanning of the plates was carried out at 254 nm. For the HPLC–UV method C 18 column was used with an isocratic elution mobile phase composed of water:acetonitrile (75:25, v/v; pH 3.2) and the detection was at 210 nm. For the UPLC-MS/MS method; separation was performed on a UPLC-BEH C 18 column with methanol: 0.1% ammonium formate (60:40, v/v) as the mobile phase utilizing diphenhydramine as an internal standard and mass spectrometry was used for detection. The methods were simple, sensitive, accurate and precise. Statistical analysis revealed no significant difference from the reported methods in regard to accuracy and precision. Electronic supplementary material The online version of this article (10.1186/s13065-019-0595-6) contains supplementary material, which is available to authorized users.

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“…Commercially available combined dosage forms (PAR+ALP) includes STS tablets (Emcure Laboratories). Literature survey revealed that development of various spectrophotometric [1][2][3][4] , HPLC [5][6][7][8][9] , HPTLC 10,11 , LCMS [12][13][14][15] and GCMS 16 methods for estimation of PAR and ALP in various dosage forms in individual and in combination with other drugs. However, there was a UV-Spectrophotometric method 2 for the simultaneous estimation of PAR and ALP in combined tablet dosage forms.…”

Section: Introductionmentioning

confidence: 99%

RP-HPLC Method Development and Validation For Simultaneous Estimation of Paracetamol and Alprazolam in Bulk and Pharmaceutical Dosage Forms

Narender¹,

Senagashetty²,

Katamaneni³

2018

AJPTR

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A new Reverse Phase High Performance Liquid Chromatographic (RP-HPLC) method has been developed for estimation of Paracetamol and Alprazolam in bulk and tablet dosage forms using UV-detector. A RP Cell Pack C18 column (250 mm × 4.6 mm, 5 µ particle size) using acetonitrile and water (80:20 % V/V) as mobile phase by maintaining flow rate of 1 mL/min at 236 nm as detection wavelength. The peaks were eluted at 4.8 and 6.2 mins for Paracetamol and Alprazolam, respectively. The method was validated in accordance with ICH guidelines, the linearity curve for Paracetamol was obtained over the range of 50-175 µg/mL, and it was found to be linear with y = 1961x + 9226 (r 2 = 0.999). The linearity curve for Alprazolam was obtained over the range of 0.25-1.5 µg/mL and was found to be linear with y =23328x + 939.3 (r 2 = 0.998). The percentage recoveries were found to be 99-101% and 99-102%, respectively. The system suitability parameters such as number of theoretical plates and tailing factor were found to be 7242, 1.56 for PAR and 6755, 1.15 for ALP. Hence the developed RP-HPLC method was found to be simple, accurate, economical, rapid and can be applied for routine analysis of these drugs in their combined formulations.

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Application of a Validated Stability-Indicating HPTLC Method for Simultaneous Estimation of Paracetamol and Aceclofenac and their Impurities

Cited by 7 publications

References 15 publications

Study of efficiency and spectral resolution for mathematical filtration technique using novel unlimited derivative ratio and classical univariate spectrophotometric methods for the multicomponent determination-stability analysis

Study of efficiency and spectral resolution for mathematical filtration technique using novel unlimited derivative ratio and classical univariate spectrophotometric methods for the multicomponent determination-stability analysis

Analytical methods for the determination of paracetamol, pseudoephedrine and brompheniramine in Comtrex tablets

RP-HPLC Method Development and Validation For Simultaneous Estimation of Paracetamol and Alprazolam in Bulk and Pharmaceutical Dosage Forms

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