A New Ecological RP-HPLC Method for the Determination of Pitavastatin, Fenofibrate and Their Impurities in a Novel Fixed Dose Combination

2022 ◽  
Author(s):  
T. S. S. Jagan Mohan ◽  
Hitesh A. Jogia ◽  
Khagga Mukkanti
Keyword(s):  
Hplc Method ◽  
Fixed Dose Combination ◽  
Fixed Dose ◽  
Rp Hplc ◽  
Dose Combination

DoE-Based Analytical Quality Risk Management for Enhanced AQbD Approach to Economical and Eco-Friendly RP-HPLC Method for Synchronous Estimation of Multiple FDC Products of Antihypertensive Drugs

2021 ◽  
Author(s):  
Pintu Prajapati ◽  
Ankita Patel ◽  
Shailesh Shah
Keyword(s):  
Risk Management ◽  
Antihypertensive Drugs ◽  
Hplc Method ◽  
Fixed Dose Combination ◽  
Fixed Dose ◽  
Analytical Quality ◽  
Quality Risk Management ◽  
Rp Hplc ◽  
Dose Combination ◽  
Quality Risk

Abstract According to the literature review, numerous chromatographic methods have been published for estimation of fixed-dose combination products of telmisartan but no reverse-phase high-pressure liquid chromatographic (RP-HPLC) method has been published yet for synchronous estimation of fixed-dose combination (FDC) products of telmisartan to save time, cost and solvent for analysis. Hence, an economical and eco-friendly RP-HPLC method has been developed for synchronous estimation of multiple FDC products of antihypertensive drugs using the quality risk management (QRM) and DoE-based enhanced analytical quality by design approach. The analytical-QRM was started with the identification of potential method risk parameters followed by their risk assessment by risk priority number ranking and filtering. The identified critical method parameters were optimized using the DoE-based central composite design. The method operable design range was navigated and the control strategy was framed for control and mitigation of risk throughout the life-cycle of the developed method. The method was developed using Shimpack Octadecyl silane (ODS) C18 column and acetonitrile-1.0%v/v triethylamine in water (pH 6.0; 45 + 55, %v/v). The developed method was validated as per the International Council for Harmonization Q2 (R1) guideline. The developed method was applied for the analysis of seven different antihypertensive dosage forms. The developed RP-HPLC method can be used as an eco-friendly, robust and economical alternative analytical tool to several published methods for estimation of FDC products of antihypertensive drugs in the pharmaceutical industry.

scholarly journals A rapid stability-indicating, fused-core HPLC method for simultaneous determination of β-artemether and lumefantrine in anti-malarial fixed dose combination products

2013 ◽  
Vol 12 (1) ◽  
pp. 145 ◽  
Author(s):  
Sultan Suleman ◽  
Kirsten Vandercruyssen ◽  
Evelien Wynendaele ◽  
Matthias D’Hondt ◽  
Nathalie Bracke ◽  
...  
Keyword(s):  
Simultaneous Determination ◽  
Hplc Method ◽  
Fixed Dose Combination ◽  
Fixed Dose ◽  
Stability Indicating ◽  
Dose Combination

scholarly journals Development and validation of an HPLC method for the simultaneous determination of artesunate and mefloquine hydrochloride in fixed-dose combination tablets

2013 ◽  
Vol 49 (4) ◽  
pp. 837-843 ◽  
Author(s):  
Fernando Henrique Andrade Nogueira ◽  
Naialy Fernandes Araújo Reis ◽  
Paula Rocha Chellini ◽  
Isabela da Costa César ◽  
Gerson Antônio Pianetti
Keyword(s):  
Simultaneous Determination ◽  
Potassium Phosphate ◽  
Hplc Method ◽  
Fixed Dose Combination ◽  
Fixed Dose ◽  
Array Detector ◽  
Control Analysis ◽  
Dose Combination ◽  
Development And Validation

The present study developed and validated an HPLC method for the simultaneous determination of artesunate (AS) and mefloquine hydrochloride (MQ) in fixed-dose combination tablets, according to ICH guidelines. The chromatographic separation was carried out on an XBridge C18 (250 x 4.6 mm i.d., 5 µm particle size, Waters) analytical column. The mobile phase included a 0.05 M monobasic potassium phosphate buffer (pH adjusted to 3.0 with phosphoric acid) and acetonitrile (50 + 50, v/v). The flow rate was 1.0 mL/min, and the run time was 13 minutes. A dual-wavelength approach was employed: AS detection was performed at 210 nm and MQ was detected at 283 nm, using a diode array detector. Stability of sample solutions was evaluated for 8 hours after preparation, during which time the solutions remained stable. Youden's test was employed to evaluate robustness. The method proved to be linear (r²>0.99), precise (RSD<2.0%), accurate, selective, and robust, proving to be appropriate for routine drug quality control analysis.

scholarly journals ENANTIOMETRIC SEPARATION OF SITAGLIPTIN IN A FIXED DOSE COMBINATION FORMULA OF SITAGLIPTIN AND METFORMIN BY A CHIRAL LIQUID CHROMATOGRAPHIC METHOD

2019 ◽  
pp. 66-71
Author(s):  
Nagadeep Jaishetty ◽  
KAMARAJ PALANISAMY ◽  
ARTHANAREESWARI MARUTHAPILLAI
Keyword(s):  
Liquid Chromatography ◽  
Mobile Phase ◽  
Gradient Elution ◽  
Hplc Method ◽  
Fixed Dose Combination ◽  
Fixed Dose ◽  
Metformin Hydrochloride ◽  
Combination Product ◽  
Dose Combination

Objective: Sitagliptin phosphate and metformin hydrochloride tablet is an FDA approved combination product for the treatment of diabetes mellitus type 2. There are no reported evidence for estimation of undesired (S)-sitagliptin in a combination product. The objective of this study was to develop a high sensitive liquid chromatography method for the determination of (S)-enantiomer of sitagliptin phosphate in a fixed dose combination formula of metformin and sitagliptin. Methods: The proposed novel high-performance liquid chromatography (HPLC) method uses programmed gradient elution of a mixture of ethanol-diethylamine(DEA) 100:0.1 (v/v) as mobile phase-A and a mixture of methanol-water 60:40 (v/v) as mobile phase-B. The chromatographic conditions were designed to nullify the metformin interference and in which sitagliptin enantiomers elute first and followed by metformin. A satisfactory resolution (≥2.5) between (S)-sitagliptin and active form (R)-sitagliptin was achieved with gradient elution on Chiralpak IA column (5μm, 4 × 250 mm) at a flow rate of 0.5 ml/min and the detector wavelength set at 265 nm. The injection volume set as 10 µl. The developed method has been validated as per the International Conference on Harmonisation (ICH) guidelines. Results: The proposed HPLC method for determination of (S)-sitagliptin, showed good linearity in the concentration range of 0.5 µg/ml to 13.6 µg/ml and capable to quantify accurately up to the lowest level (LOQ) of 0.017%. The validated method was successfully applied to quantify the (S)-sitagliptin for different marketed formulations of sitagliptin with metformin and sitagliptin alone, and the corresponding recovery values were found to be in the range of 95.1% to 98.4%. Conclusion: The proposed validated HPLC method was found to be suitable for the quantitative determination of (S)-sitagliptin in the formulations of sitagliptin with metformin and sitagliptin alone.

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