A New Force Indicating RP-HPLC Method Development and Validation for the Simultaneous Estimation of Pibrentasvir and Glecaprevir in Bulk and its Tablet Dosage Form

Babu, D. China; Chetty, C. Madhusudhana; Mastanamma, Sk.

doi:10.5530/phm.2018.2.14

Cited by 10 publications

(11 citation statements)

References 2 publications

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“…The method responses selected were Retention time of the drug and resolution between degradant peak 1 and degradant peak 2 which likely co-elute and lead to method failure often. Preferably in response surface method, 2 3 factorial designs were selected. The selected method responses and its levels were given in Table-3.…”

Section: Selection Of Chromatographic Conditionsmentioning

confidence: 99%

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Development, Optimization and Validation of a Selective Stability Indicating RP-HPLC Method for Estimation of Glecaprevir and Pibrentasvir and Its Degradation Products Using Quality by Design Approach

Vanitha¹,

Satyanarayana²,

Reddy³

2019

Asian J. Chem.

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The present work focused on QbD driven approach for the development, optimization of stability indicating method for glecaprevir and pibrentasvir in bulk drug and its degradation products. The chromatographic separation was performed on Hypersil C8 (150 mm × 4.6, 5 µ) with a flow rate of 1 mL/min at 260 nm. The mobile phase employed was sodium phosphate monobasic and monohydric buffer and acetonitrile (65:35) having pH of 4.2 at 30 °C of column temperature. The degradation studies were carried out for glecaprevir and pibrentasvir under the stress condition hydrolysis (acid, base and neutral), oxidation, photolytic and thermal as per ICH guidelines. In alkali degradation chromatogram, more number of degradant peaks was appeared along with the risk factor, selectivity of the method. The selectivity of the method was established by resolving the resolution of degradant peaks and retention time of drugs by the application of design of experiment. The interaction effect of factors of pH mobile phase, column temperature and % mobile phase were studied through response surface method (RSM) and central composite design (CCD). The optimized selective method was established for the detection of glecaprevir and pibrentasvir along with degradant peaks by optimized conditions were proposed by the model. Then the optimized method was validated for the parameters like linearity, accuracy, precision and robustness as per ICH guidelines.

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Section: Selection Of Chromatographic Conditionsmentioning

confidence: 99%

“…The NS5A is responsible for viral replication and virions assemble of virus which is inhibited by pibrentasvir [2]. In the literature few analytical methods has been reported like RP-HPLC methods [3][4][5], UPLC [6] method, Stability indicating assay methods [7,8]. The drug combination…”

Section: Introductionmentioning

confidence: 99%

Development, Optimization and Validation of a Selective Stability Indicating RP-HPLC Method for Estimation of Glecaprevir and Pibrentasvir and Its Degradation Products Using Quality by Design Approach

Vanitha¹,

Satyanarayana²,

Reddy³

2019

Asian J. Chem.

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“…Hitherto, only one HPLC [10] and one UPLC [11] methods are reported for the concurrent determination of pibrentasvir and glecaprevir. There is one method [12] established till date in simultaneous quantification of pibrentasvir and glecaprevir in bulk and tablet dosage forms using stability indicating RP-HPLC. The current study describes a novel, simple, precise and rapid stability indicating RP-HPLC method with UV detection for the simultaneous estimation of pibrentasvir and glecaprevir in bulk and in tablets with a run time of 10 min and less retention time.…”

Section: Introductionmentioning

confidence: 99%

Stability-indicating high performance liquid chromatographic method for simultaneous assay of pibrentasvir and glecaprevir: Method development, validation and application to tablet dosage forms

Mamidi¹,

Atmakuri²,

Mamidipalli³

2019

jrp

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“…Glecaprevir mainly acts as hepatitis C Virus nonstructural protein 3/4A protease inhibitor (Babu et al, 2018;GampaVijayKumar and Reddy, 2018;Kumar and Raja, 2018) It is used for the treatment of chronic hepatitis C Infection along Pibrentasvir.…”

Section: Introductionmentioning

confidence: 99%

Stability indicating RP-HPLC method development and validation for the simultaneous estimation of pibrentasvir and glecaprevir in bulk and pharmaceutical dosage form

Harikrishnan¹,

M²,

Subramanian³

et al. 2019

ijrps

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A plain sailing, unambiguous, speedy and error-free methodology was progressed for the quantifiable concurrent estimation of Pibrentasvir and Glecaprevir in conglomerated pharmaceutical dosage form. The contrivance was based on Chromatographic separation of both the drugs in reverse phase mode using C18 (250 X 4.6 mm), 5μ by utilizing phosphate buffer (pH 4.0) and Methyl alcohol in the ratio of 30:70 v/v was allowed to flow through column at a rate of 1.0 ml/min, and the detection wavelength was set at 251 nm. The time of retention was found to be 2.205 min for Glecaprevir and 4.996 min for Pibrentasvir. The dimensionality of Glecaprevir and Pibrentasvir was in linear range with a parametric statistic of 0.999 and 0.999. The acceptance criteria of precision was RSD should be not more than 2.0%, and the method showed precision 0.6 and 0.5 for Glecaprevir and Pibrentasvir, which shows that the method was precise. % Assay was found as 100.83 and 100.23, which show that the method was useful for routine analysis. The total recovery was founded to be100.40% and 100.25% for Glecaprevir and Pibrentasvir. LOD and LOQ for Glecaprevirwas found as 2.98 and 10.00 and LOD and LOQ for Pibrentasvir was found as 3.00 and 9.98. The methodology was assessed by various validation parameters in accordance with ICH Guidelines which indicates the method can be employed for routine quality control analysis.

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A New Force Indicating RP-HPLC Method Development and Validation for the Simultaneous Estimation of Pibrentasvir and Glecaprevir in Bulk and its Tablet Dosage Form

Cited by 10 publications

References 2 publications

Development, Optimization and Validation of a Selective Stability Indicating RP-HPLC Method for Estimation of Glecaprevir and Pibrentasvir and Its Degradation Products Using Quality by Design Approach

Development, Optimization and Validation of a Selective Stability Indicating RP-HPLC Method for Estimation of Glecaprevir and Pibrentasvir and Its Degradation Products Using Quality by Design Approach

Stability-indicating high performance liquid chromatographic method for simultaneous assay of pibrentasvir and glecaprevir: Method development, validation and application to tablet dosage forms

Stability indicating RP-HPLC method development and validation for the simultaneous estimation of pibrentasvir and glecaprevir in bulk and pharmaceutical dosage form

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