An Innovative Method Development and Forced Degradation Studies for Simultaneous Estimation of Sofosbuvir and Ledipasvir by Rp HPLC

Reddy, B. Anjaneyulu; Alam, Irshad; Khanam, Nazia; Adhakrishnanand, P. R.

doi:10.22159/ijpps.2019v11i2.29347

Cited by 9 publications

(10 citation statements)

References 10 publications

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“…The resulting linearity solutions were infused into a chromatographic system, and from the chromatograms, the linearity graph was plotted by taking the peak area on Y-axis and concentration on X-axis. [17,18] The calibration graphs were shown in Table 1 and Figs 3 to 5, and all findings were within limits.…”

Section: Linearitymentioning

confidence: 62%

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Stability-Indicating Method Development and Validation for Simultaneous Estimation of Ombitasvir, Paritaprevir, and Ritonavir in Formulation by Ultra Performance Liquid Chromatography

Maneka

Kumar

Male³

2020

Int. J. Pharm. Sci. Drug Res.

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Aim of the present research work was to develop a sensitive, precise and robust stability-indicating UPLC method for the simultaneous estimation of ombitasvir, paritaprevir and ritonavir in formulations. The chromatographic separation of mixture of ombitasvir, paritaprevir and ritonavir was attained in isocratic method utilizing a mobile phase of 0.01N Potassium dihydrogen orthophosphate (pH 5.3) and methanol in the proportion of 60:40%v/v utilizing a BEH C18 column which has dimensions of 100 x 3 mm, 1.7m particle size and the flow rate of 0.3 ml/min. The detection system was monitored at 252nm wavelength maximum with 0.2 ml injection volume. The retaining time for ombitasvir, paritaprevir and ritonavir was achieved at 1.765 min, 2.192 min, and 1.326 min respectively. Ombitasvir, paritaprevir and ritonavir and their combined drug formulation were exposed to thermal, acidic, oxidative, photolytic, and alkaline conditions. The present method was validated as per the guidelines given by the ICH for specificity, accuracy, sensitivity, linearity and precision. The developed method was highly sensitive, rapid, precise and accurate than the earlier reported methods. The total run time was decreased to 3.0 min; hence, the technique was more precise and economical. Stability studies directed for the suitability of the technique for degradation studies of ombitasvir, paritaprevir and ritonavir. The projected method can be utilized for routine analysis in quality control department in pharmaceutical trades.

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Section: Linearitymentioning

confidence: 62%

“…The developed method for OMTR, PRTR, and RTNR was subjected for validation for the parameters, like the limit of detection (LOD), the limit of quantification (LOQ), linearity, robustness, precision, system suitability, and accuracy as per the guidelines of ICH. [15][16][17][18]…”

Section: Analytical Methods Validationmentioning

confidence: 99%

Stability-Indicating Method Development and Validation for Simultaneous Estimation of Ombitasvir, Paritaprevir, and Ritonavir in Formulation by Ultra Performance Liquid Chromatography

Maneka

Kumar

Male³

2020

Int. J. Pharm. Sci. Drug Res.

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“…known as multidrug therapy; as the numbers of doses are reduced, this multidrug therapy has better patient acceptability. In the present study, we had tried to develop an innovative, simple, rapid, precise, and accurate method for contemporaneous determination of multicomponent system of dextromethorphan hydrobromide (DXB) and desloratadine (DES) in a monophasic liquid dosage form, that is, syrup preparation by RP-HPLC and validate it according to the International council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines [1]. DXB is centrally acting nonopioid anti-tussive drug used for effective treatment of cough and asthma.…”

Section: F I G U R E 1 Structure Of Dextromethorphan Hydrobromide (A)mentioning

confidence: 99%

A multivariate quantification of Box‐Behnken design assisted method development and validation of dextromethorphan hydrobromide and desloratadine simultaneously by reverse‐phase HPLC in in‐house syrup formulation

Alam

Siddiqui

Khanam

et al. 2020

J of Separation Science

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An innovative high‐performance liquid chromatography assay method was developed and validated for quantification of dextromethorphan hydrobromide and desloratadine simultaneously in monophasic liquid formulation by preparing syrup containing 30 mg/5 mL of dextromethorphan hydrobromide and 1.2 mg/mL of desloratadine. The chromatographic severance was executed by gradient solution A and B. The composition of buffer solution A contained 0.05 M monobasic potassium, then 1 mL triethylamine was added to it and the pH was adjusted to 2.3 with orthophosphoric acid. Methanol was used as solution B. The gradient elution was executed with Kromasil C8 (250 mm × 4.6 mm) column having 1.5 mL/min flow rate and 20 µL injection volume with UV‐estimation at 254 nm for dextromethorphan hydrobromide and DES. The present research was planned according to Box‐Behnken design by utilizing design expert software, using four factors such as column temperature (A), flow rate (B), mobile phase–organic phase (C), and pH (D); correspondingly the selected response variables were resolution between A and B, that is, desloratadine and methyl paraben (Y1), tailing of dextromethorphan hydrobromide (Y2), and tailing of desloratadine (Y3). The parameters such as system suitability, linearity, accuracy, precision, robustness, limit of detection, limit of quantitation, and ruggedness were analyzed to validate the developed method in accordance with current regulatory guidelines.

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“…The literature review discloses that a very few spectroscopic, [7,8] LC-MS/MS, [9] and high performance liquid chromatographic techniques [10][11][12][13][14][15][16] have been reported for the estimation of VXR, SFR, and VLR. Based on the reported HPLC methods, there is a need to develop a rapid, sensitive reversed-phase-UPLC method for simultaneous estimation of VXR, SFR, and VLR in bulk and formulations.…”

Section: Original Articlementioning

confidence: 99%

Untitled

Maneka¹

2020

AJP

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Aim: The aim of the present research work was to develop a sensitive, rapid and accurate, stability-indicating RP-UPLC method for the simultaneous estimation of voxilaprevir (VXR), sofosbuvir (SFR), and velpatasvir (VLR) in formulations. Materials and Methods: The chromatographic separation of mixture of VXR, SFR, and VLR was attained in isocratic method utilizing a mobile phase of 0.01N potassium dihydrogen orthophosphate (pH 4.8) and methanol in the proportion of 50:50% v/v utilizing a CHS C18 column which has dimensions of 100 × 2.1 mm, 2.0 m particle size and the flow rate of 1.0 mL/min. The detection system was monitored at 260 nm wavelength maximum with 1.0 mL injection volume. Results: The retaining time for VXR, SFR, and VLR was achieved at 1.468 min, 0.606 min, and 0.848 min, respectively. VXR, SFR, and VLR and their combined drug formulation were exposed to thermal, acidic, oxidative, photolytic, and alkaline conditions. The present method was validated as per the guidelines given by the ICH for specificity, accuracy, sensitivity, linearity, and precision. Conclusion: The developed method was highly sensitive, rapid, precise, and accurate than the earlier reported methods. The total run time was decreased to 3.0 min; hence, the technique was more precise and economical. Stability studies directed for the suitability of the technique for degradation studies of VXR, SFR, and VLR. The projected method can be utilized for routine analysis in quality control department in pharmaceutical trades.

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An Innovative Method Development and Forced Degradation Studies for Simultaneous Estimation of Sofosbuvir and Ledipasvir by Rp HPLC

Cited by 9 publications

References 10 publications

Stability-Indicating Method Development and Validation for Simultaneous Estimation of Ombitasvir, Paritaprevir, and Ritonavir in Formulation by Ultra Performance Liquid Chromatography

Stability-Indicating Method Development and Validation for Simultaneous Estimation of Ombitasvir, Paritaprevir, and Ritonavir in Formulation by Ultra Performance Liquid Chromatography

A multivariate quantification of Box‐Behnken design assisted method development and validation of dextromethorphan hydrobromide and desloratadine simultaneously by reverse‐phase HPLC in in‐house syrup formulation

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