Analytical QbD based systematic development of a novel RP-UHPLC method for the quantification of albuterol sulphate in its metered dose inhaler formulations

N.A.

Article Details

Analytical QbD based systematic development of a novel RP-UHPLC method for the quantification of albuterol sulphate in its metered dose inhaler formulations

Authors:

N.A.

Publisher:

Marmara University

Main Topics:

Pharmaceutical Analytical Chemistry

Journal:

Journal of Research in Pharmacy Vol.25 Issue 5, pp.689-701

Document Type:

Article

Publication Date:

6/2025

Document Language:

English

Document ID (Org No.):

2001346235

pISSN:

2630-6344

Keywords:

Abstract:

 Albuterol sulphate is a Beta-2adrenergic agonist drug mainly used in the form of nasal inhalations to treat chronic bronchitis and chronic obstructive pulmonary disease COPD. A simple, rapid, precise chemometrics- based RP-UHPLC method has been developed and validated in its MDI formulations by the QbD approach. The chromatographic separation was achieved by Hibar HR purospher STAR RP-18 encapped column C18, 250 mm  4.6 mm, 5 μm with UV detection λmax 225 nm. The retention time Rt for albuterol sulphate was observed as 2.434 over a run time of 5 minutes. Optimization of the method for the quantification of albuterol sulphate in its metered dose inhaler formulations has been performed by using 22 central composite design with response surface methodology that might lessen the solvent consumption, duration, and additional resources. A total of two independent variables, organic phase composition, and flow rate, were analyzed to construct a quadratic process model to examine the effect of independent variables or critical material attributes CMAs ahead the observed responses known as the critical method parameters CMPs within the designed space. The optimized UHPLC method contains phosphate buffer 10 mM KH2PO4 and acetonitrile 60:40 vv as the mobile phase, which was delivered with a flow rate of 1.0 mlmin and the column was maintained at 40C. The developed QbD based method was subsequently validated as per ICH Q2 R1 guidelines. The method obeyed linearity within the range of 5-120 μgmL with regression R2 of 0.999 for albuterol sulphate. The low coefficients of variation obtained in the intraday and inter-day precision studies indicate précised method. High recovery of albuterol sulphate has been observed within the range of 98.0-102.0 . The developed method can be intensely employed as a highly robust, accurate, and cost-effective for routine analysis in research labs that competitively separate the drug from its excipients.

 Albuterol sulphate is a Beta-2adrenergic agonist drug mainly used in the form of nasal inhalations to treat chronic bronchitis and chronic obstructive pulmonary disease COPD. A simple, rapid, precise chemometrics- based RP-UHPLC method has been developed and validated in its MDI formulations by the QbD approach. The chromatographic separation was achieved by Hibar HR purospher STAR RP-18 encapped column C18, 250 mm  4.6 mm, 5 μm with UV detection λmax 225 nm. The retention time Rt for albuterol sulphate was observed as 2.434 over a run time of 5 minutes. Optimization of the method for the quantification of albuterol sulphate in its metered dose inhaler formulations has been performed by using 22 central composite design with response surface methodology that might lessen the solvent consumption, duration, and additional resources. A total of two independent variables, organic phase composition, and flow rate, were analyzed to construct a quadratic process model to examine the effect of independent variables or critical material attributes CMAs ahead the observed responses known as the critical method parameters CMPs within the designed space. The optimized UHPLC method contains phosphate buffer 10 mM KH2PO4 and acetonitrile 60:40 vv as the mobile phase, which was delivered with a flow rate of 1.0 mlmin and the column was maintained at 40C. The developed QbD based method was subsequently validated as per ICH Q2 R1 guidelines. The method obeyed linearity within the range of 5-120 μgmL with regression R2 of 0.999 for albuterol sulphate. The low coefficients of variation obtained in the intraday and inter-day precision studies indicate précised method. High recovery of albuterol sulphate has been observed within the range of 98.0-102.0 . The developed method can be intensely employed as a highly robust, accurate, and cost-effective for routine analysis in research labs that competitively separate the drug from its excipients.

 Albuterol sulphate is a Beta-2adrenergic agonist drug mainly used in the form of nasal inhalations to treat chronic bronchitis and chronic obstructive pulmonary disease COPD. A simple, rapid, precise chemometrics- based RP-UHPLC method has been developed and validated in its MDI formulations by the QbD approach. The chromatographic separation was achieved by Hibar HR purospher STAR RP-18 encapped column C18, 250 mm  4.6 mm, 5 μm with UV detection λmax 225 nm. The retention time Rt for albuterol sulphate was observed as 2.434 over a run time of 5 minutes. Optimization of the method for the quantification of albuterol sulphate in its metered dose inhaler formulations has been performed by using 22 central composite design with response surface methodology that might lessen the solvent consumption, duration, and additional resources. A total of two independent variables, organic phase composition, and flow rate, were analyzed to construct a quadratic process model to examine the effect of independent variables or critical material attributes CMAs ahead the observed responses known as the critical method parameters CMPs within the designed space. The optimized UHPLC method contains phosphate buffer 10 mM KH2PO4 and acetonitrile 60:40 vv as the mobile phase, which was delivered with a flow rate of 1.0 mlmin and the column was maintained at 40C. The developed QbD based method was subsequently validated as per ICH Q2 R1 guidelines. The method obeyed linearity within the range of 5-120 μgmL with regression R2 of 0.999 for albuterol sulphate. The low coefficients of variation obtained in the intraday and inter-day precision studies indicate précised method. High recovery of albuterol sulphate has been observed within the range of 98.0-102.0 . The developed method can be intensely employed as a highly robust, accurate, and cost-effective for routine analysis in research labs that competitively separate the drug from its excipients.

 Albuterol sulphate is a Beta-2adrenergic agonist drug mainly used in the form of nasal inhalations to treat chronic bronchitis and chronic obstructive pulmonary disease COPD. A simple, rapid, precise chemometrics- based RP-UHPLC method has been developed and validated in its MDI formulations by the QbD approach. The chromatographic separation was achieved by Hibar HR purospher STAR RP-18 encapped column C18, 250 mm  4.6 mm, 5 μm with UV detection λmax 225 nm. The retention time Rt for albuterol sulphate was observed as 2.434 over a run time of 5 minutes. Optimization of the method for the quantification of albuterol sulphate in its metered dose inhaler formulations has been performed by using 22 central composite design with response surface methodology that might lessen the solvent consumption, duration, and additional resources. A total of two independent variables, organic phase composition, and flow rate, were analyzed to construct a quadratic process model to examine the effect of independent variables or critical material attributes CMAs ahead the observed responses known as the critical method parameters CMPs within the designed space. The optimized UHPLC method contains phosphate buffer 10 mM KH2PO4 and acetonitrile 60:40 vv as the mobile phase, which was delivered with a flow rate of 1.0 mlmin and the column was maintained at 40C. The developed QbD based method was subsequently validated as per ICH Q2 R1 guidelines. The method obeyed linearity within the range of 5-120 μgmL with regression R2 of 0.999 for albuterol sulphate. The low coefficients of variation obtained in the intraday and inter-day precision studies indicate précised method. High recovery of albuterol sulphate has been observed within the range of 98.0-102.0 . The developed method can be intensely employed as a highly robust, accurate, and cost-effective for routine analysis in research labs that competitively separate the drug from its excipients.

Article Details

Analytical QbD based systematic development of a novel RP-UHPLC method for the quantification of albuterol sulphate in its metered dose inhaler formulations

Authors:

N.A.

Publisher:

Marmara University

Main Topics:

Pharmaceutical Analytical Chemistry

Journal:

Journal of Research in Pharmacy Vol.25 Issue 5, pp.689-701

Document Type:

Article

Publication Date:

6/2025

Document Language:

English

Document ID (Org No.):

2001346235

pISSN:

2630-6344

Accuracy

validation

isocratic

experimental design

albuterol sulphate

correlation coefficient

Issues

Article Details

Analytical QbD based systematic development of a novel RP-UHPLC method for the quantification of albuterol sulphate in its metered dose inhaler formulations

Authors: N.A.

Publisher: Marmara University

Main Topics: Pharmaceutical Analytical Chemistry

Journal: Journal of Research in Pharmacy Vol.25 Issue 5, pp.689-701

Document Type: Article

Publication Date: 6/2025

Document Language: English

Document ID (Org No.): 2001346235

pISSN: 2630-6344

Accuracy

validation

isocratic

experimental design

albuterol sulphate

correlation coefficient

Issues

Authors:

N.A.

Publisher:

Marmara University

Main Topics:

Pharmaceutical Analytical Chemistry

Journal:

Journal of Research in Pharmacy Vol.25 Issue 5, pp.689-701

Document Type:

Article

Publication Date:

6/2025

Document Language:

English

Document ID (Org No.):

2001346235

pISSN:

2630-6344