Application of HPTLC-densitometry by Derivatization and Stability Indicating LC for Simultaneous Determination of Mefloquine Hydrochloride and Artesunate in Combined Dosage form

Sandhya, S.; Kumar, Pushpangadhan S. Shiji; Meena, Sunita

doi:10.9734/acsj/2015/16292

Cited by 4 publications

(2 citation statements)

References 17 publications

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“…Therefore, it was thought to develop a stability-indicating RP-HPLC method for ART, PYR, and sulfadoxin in combination by the novel approach of QbD. [13][14][15][16][17][18][19][20][21][22][23][24][25][26]…”

Section: Software-aided Methods Optimizationmentioning

confidence: 99%

Untitled

2023

AJP

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Introduction: Artesunate (ART) is a prodrug used as an antimalarial agent that acts by malarial protein damage through alkylation. Pyrimethamine (PYR) is an antiprotozoal agent that acts by interfering with the synthesis of tetrahydrofolic acid. Sulfadoxine is a dihydropteroate synthetase inhibiter which makes difficulty in parasite reproduction. A stability-indicating high-performance liquid chromatography (HPLC) technique has been established for the quantification of PYR, sulfadoxin, and ART applying design of experiment. Material and Methods: The phosphate buffer (pH 3.0):acetonitrile (80: 20) was used as the mobile phase, and hypersil BDS C18 (250 × 4.6 mm; 4 m) column at a flow rate of 1 mL/min was used for the chromatographic separation. The detection wavelength was set at 237 nm. The mobile phase was optimized using 3 2 full factorial design. Results and Discussion: The optimized method contains the retention times of PYR, sulfadoxin, and ART at 3.653, 4.920, and 8.310 min, respectively. The method shows a good linearity in the concentration range of 0.5-2.5 μg/mL for PYR, 10-50 μg/mL for sulfadoxin, and 4-20 μg/mL for ART. The stability study of the drugs was performed by acid, alkali, oxidation, thermal, and photolytic degradation. Conclusion: The proposed stability indicating HPLC method was found to be simple, specific, practical, accurate, quick, and affordable. It was also suitable for the routine analysis, quality control, and percentage degradation of pharmaceutical preparations containing these drugs either individually or in combination.

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Section: Software-aided Methods Optimizationmentioning

confidence: 99%

Untitled

2023

AJP

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“…Several methods for the simultaneous quantification these drugs can be found in the literature, such as ultraviolet (UV) spectrophotometry [ 10 , 11 ], high performance liquid chromatography (HPLC) with UV spectrophotometry detection [ 12 , 13 ], high performance thin layer chromatography (HPTLC) with UV spectrophotometry detection [ 13 , 14 ], and HPLC coupled with tandem mass spectroscopy (HPLC–MS/MS) [ 15 ]. Despite being very commonly used, no methods for quality control of available products are described in the pharmacopoeias [ 16 – 19 ].…”

Section: Introductionmentioning

confidence: 99%

Simultaneous quantification of artesunate and mefloquine in fixed-dose combination tablets by multivariate calibration with middle infrared spectroscopy and partial least squares regression

Marson

Vilhena

Madeira

et al. 2016

Malar J

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BackgroundMalaria is one of the most lethal and life-threatening infectious diseases in the world, causing more than half a million deaths annually. Treatment with mefloquine and artesunate is currently recommended by the World Health Organization, and was historically the first artemisinin-based combination therapy used clinically for treatment of Plasmodium falciparum. The problem of poor-quality medicines, such as counterfeit and sub-standard anti-malarials, is a worldwide issue; therefore, it is essential to develop rapid, low cost, solvent-free, and reliable methods for routine quality control for these drugs. The aim of this study was to develop and validate a novel multivariate method for direct simultaneous quantification of mefloquine and artesunate in tablets by diffuse reflectance, middle infrared spectroscopy and partial least squares regression (MIR-PLS).MethodsDiffuse reflectance infrared Fourier transform spectroscopy (DRIFTS) and partial least squares regression were applied for simultaneous quantification of artesunate and mefloquine in tablets provided by the Brazilian Government. The model was obtained with full spectra (4000–400 cm−1) preprocessed by first derivative and Savitzky-Golay smoothing followed by mean centring, and built with three latent variables. The method was validated according to Brazilian and international guidelines through the measuring of figures of merit, such as trueness, precision, linearity, analytical sensitivity, selectivity, bias, and residual prediction deviation. The results were compared to an HPLC–MS/MS method.ResultsThe MIR-PLS method provided root mean square errors of prediction lower than 2.0 mg per 100 mg of powder for the two analytes, and proved to be valid according to guidelines for analytical methods that use infrared (IR) spectroscopy with multivariate calibration. For the samples obtained from Brazilian healthcare units, the method provided results statistically similar to those obtained by HPLC–MS/MS.ConclusionMIR-PLS was found to be suitable for the quality control of these drugs. It is fast, does not use solvents, and does not generate chemical waste. Furthermore, the proposed method may be transferred and developed for use in portable equipment, increasing the possibilities for assessing the quality of these drugs.

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