Development of validation of a rapid and simple analytical separation method for anticancer alkylating agents using application of total error concept

N.A.

Makale detayları

Development of validation of a rapid and simple analytical separation method for anticancer alkylating agents using application of total error concept

Yazarlar:

N.A.

Yayıncı:

Marmara University

Ana Başlıklar:

Pharmaceutical Chemistry

Dergi:

Journal of Research in Pharmacy Vol.26 Issue 2, pp.431-443

Belge Tipi:

Makale

Yayın Tarihi:

6/2025

Belge Dili:

İngilizce

Document ID (Org No.):

2001346350

pISSN:

2630-6344

Anahtar kelimeler:

Özet:

 A simple and sensitive high-performance liquid chromatographic HPLC method is established to separate and quantify the related substance present in two alkylating agents. The use of the traditional approach of analytical validation, in practice or in the literature, is communal. However, statistical verification, that looks separately the two errors such as absolute bias and repeatability to make a decision, presents a risk to declare that an analytical method is valid while it is not, or equally. To minimize this peril, a new approach based on the concept of total error was proposed. In this paper, we reveal the applicability and simplicity of the both methods based on the total error approach: accuracy profile and uncertainty profile. Proposed study demonstrated by validation case of a liquid chromatographic LC method for the quantification of related compounds present in two alkylating agents. Both methods showed good linearity response  0.995 with repeatability relative standard deviation less than 2 and accuracy 94 to 106. Accuracy profile was found within the range of 10 and risk profile 5 between the two series respectively. The excellence of the total error approach was presented since it enables successfully to validate the analytical procedure as well the calculation of the measurement uncertainty at each concentration level.

 A simple and sensitive high-performance liquid chromatographic HPLC method is established to separate and quantify the related substance present in two alkylating agents. The use of the traditional approach of analytical validation, in practice or in the literature, is communal. However, statistical verification, that looks separately the two errors such as absolute bias and repeatability to make a decision, presents a risk to declare that an analytical method is valid while it is not, or equally. To minimize this peril, a new approach based on the concept of total error was proposed. In this paper, we reveal the applicability and simplicity of the both methods based on the total error approach: accuracy profile and uncertainty profile. Proposed study demonstrated by validation case of a liquid chromatographic LC method for the quantification of related compounds present in two alkylating agents. Both methods showed good linearity response  0.995 with repeatability relative standard deviation less than 2 and accuracy 94 to 106. Accuracy profile was found within the range of 10 and risk profile 5 between the two series respectively. The excellence of the total error approach was presented since it enables successfully to validate the analytical procedure as well the calculation of the measurement uncertainty at each concentration level.

 A simple and sensitive high-performance liquid chromatographic HPLC method is established to separate and quantify the related substance present in two alkylating agents. The use of the traditional approach of analytical validation, in practice or in the literature, is communal. However, statistical verification, that looks separately the two errors such as absolute bias and repeatability to make a decision, presents a risk to declare that an analytical method is valid while it is not, or equally. To minimize this peril, a new approach based on the concept of total error was proposed. In this paper, we reveal the applicability and simplicity of the both methods based on the total error approach: accuracy profile and uncertainty profile. Proposed study demonstrated by validation case of a liquid chromatographic LC method for the quantification of related compounds present in two alkylating agents. Both methods showed good linearity response  0.995 with repeatability relative standard deviation less than 2 and accuracy 94 to 106. Accuracy profile was found within the range of 10 and risk profile 5 between the two series respectively. The excellence of the total error approach was presented since it enables successfully to validate the analytical procedure as well the calculation of the measurement uncertainty at each concentration level.

 A simple and sensitive high-performance liquid chromatographic HPLC method is established to separate and quantify the related substance present in two alkylating agents. The use of the traditional approach of analytical validation, in practice or in the literature, is communal. However, statistical verification, that looks separately the two errors such as absolute bias and repeatability to make a decision, presents a risk to declare that an analytical method is valid while it is not, or equally. To minimize this peril, a new approach based on the concept of total error was proposed. In this paper, we reveal the applicability and simplicity of the both methods based on the total error approach: accuracy profile and uncertainty profile. Proposed study demonstrated by validation case of a liquid chromatographic LC method for the quantification of related compounds present in two alkylating agents. Both methods showed good linearity response  0.995 with repeatability relative standard deviation less than 2 and accuracy 94 to 106. Accuracy profile was found within the range of 10 and risk profile 5 between the two series respectively. The excellence of the total error approach was presented since it enables successfully to validate the analytical procedure as well the calculation of the measurement uncertainty at each concentration level.

Makale detayları

Development of validation of a rapid and simple analytical separation method for anticancer alkylating agents using application of total error concept

Yazarlar:

N.A.

Yayıncı:

Marmara University

Ana Başlıklar:

Pharmaceutical Chemistry

Dergi:

Journal of Research in Pharmacy Vol.26 Issue 2, pp.431-443

Belge Tipi:

Makale

Yayın Tarihi:

6/2025

Belge Dili:

İngilizce

Document ID (Org No.):

2001346350

pISSN:

2630-6344

Related substances

Quantification

Total error

HPLC

Validation

Sayı

Makale detayları

Development of validation of a rapid and simple analytical separation method for anticancer alkylating agents using application of total error concept

Yazarlar: N.A.

Yayıncı: Marmara University

Ana Başlıklar: Pharmaceutical Chemistry

Dergi: Journal of Research in Pharmacy Vol.26 Issue 2, pp.431-443

Belge Tipi: Makale

Yayın Tarihi: 6/2025

Belge Dili: İngilizce

Document ID (Org No.): 2001346350

pISSN: 2630-6344

Related substances

Quantification

Total error

HPLC

Validation

Sayı

Yazarlar:

N.A.

Yayıncı:

Marmara University

Ana Başlıklar:

Pharmaceutical Chemistry

Dergi:

Journal of Research in Pharmacy Vol.26 Issue 2, pp.431-443

Belge Tipi:

Makale

Yayın Tarihi:

6/2025

Belge Dili:

İngilizce

Document ID (Org No.):

2001346350

pISSN:

2630-6344