Stability Indicating RP-HPLC Method for the Simultaneous Estimation of Pyrimethamine and Sulphadoxine in Bulk and Tablet Dosage Form

Kumar, Veeragoni Anil; Sindgi, Vasudeva Murthy; Satla, Shoba Rani; Thimmaraju, Manish Kumar

doi:10.7324/japs.2016.60312

Cited by 5 publications

(4 citation statements)

References 10 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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“…Sulfonamide is very slightly soluble in water; slightly soluble in alcohol and in methanol; practically insoluble in ether; soluble in dilute mineral acids and in solutions of alkali hydroxides and carbonates. It has a molecular formula of C 12 H 14 N 4 O 4 S, and molecular weight of 310.33 g/mol as shown in figure (1) (Anil et al 2016, Sushil et al 2021. Pyrimethamine and sulfadoxine is official in USP Pharmacopoeia, and world malaria report (Bergqvist et al 1991).…”

Section: Introductionmentioning

confidence: 99%

Development and Validation of Lc-MS Method for Simultaneous Determination of Pyrimethamine and Sulfadoxine in the Pharmaceutical Preparation

Nassar,

El-Olemy,

Emara

et al. 2023

Al-Azhar Journal of Pharmaceutical Sciences

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A simple, sensitive, accurate and precise liquid chromatography mass spectrometry (LC-MS) method was developed for determination of pyrimethamine and sulfadoxine in pharmaceutical formulation. The chromatographic separation was performed on Phenomenex C18 column (I.D. 250 mm x 4.6mm, 5μm) and the column oven temperature was set at 30 ºC, with an injection volume of 5 μl, acetonitrile and Phosphate buffer in the ratio 75: 25 (v/v) at pH 2.5 as mobile phase. The Electrospray Ionization (ESI) was performed using nitrogen gas to assist nebulization (flow rate was set at 1.0 mL/min), the mass spectrometer was operated in the multiple reaction monitoring (MRM) mode. As part of the method validation, specificity, limit of detection (LOD), limit of quantification (LOQ), linearity, accuracy, precision and robustness were determined. The limit of detection and limit of quantification for pyrimethamine and sulfadoxine were 0.69 and 0.82 ng/mL, and limit of quantification for pyrimethamine and sulfadoxine were 2.29 and 2.73 ng/mL respectively. The intraand inter-day precisions were lower than 0.53% while the accuracy ranged from 99.99% to 100.11%. The admissible robustness indicates that the method remains unaffected by small but deliberate variations.

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“…The review of literature for PYR and SLP throws light on the studies performed on these drugs. There were many methods developed for PYR with a combination of sulfadoxine, by HPLC, HPTLC and spectrophotometric techniques (Acheampong et al, 2018;Green et al, 2002;Kumar et al, 2016;Onah and Odeiani, 2002;Meena and Sandhya, 2013;Meena and Sandhya, 2013;Nevado et al, 2000;Knupp et al, 1986). Pharmacokinetic study of PYR and bioavailability studies were also performed (Coleman et al, 1986;Dhapte et al, 2013).…”

Section: Introductionmentioning

confidence: 99%

Stability indicating RP-HPLC method for simultaneous determination of pyrimethamine and sulfamethoxypyrazine in pharmaceutical formulation: Application to method validation

2020

J app pharm sci

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The present work takes into account the development of Reverse Phase High Performance Liquid Chromatography (HPLC) for simultaneous method estimation and validation of pyrimethamine and sulfamethoxypyrazine in pharmaceutical formulation. The chromatographic separation was accomplished on C8 column by using acetonitrile and potassium dihydrogen phosphate as the mobile phase (60:40 v/v) having a flow rate of 0.8 ml/minute. The eluent was detected at 254 nm, simultaneously for both the drugs. The retention time for pyrimethamine and sulfamethoxypyrazine was found to be 3.33 and 4.21 minutes, respectively. According to the International Conference on Harmonisation guidelines, the develop method was validated in terms of accuracy, precision, linearity, limit of detection, limit of quantitation, robustness, and stress degradation studies. This validated method can be suggested for the routine simultaneous laboratory analysis of pyrimethamine and sulfamethoxypyrazine.

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Stability Indicating RP-HPLC Method for the Simultaneous Estimation of Pyrimethamine and Sulphadoxine in Bulk and Tablet Dosage Form

Cited by 5 publications

References 10 publications

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Development and Validation of Lc-MS Method for Simultaneous Determination of Pyrimethamine and Sulfadoxine in the Pharmaceutical Preparation

Stability indicating RP-HPLC method for simultaneous determination of pyrimethamine and sulfamethoxypyrazine in pharmaceutical formulation: Application to method validation

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