UTILITY OF QUALITY BY DESIGN APPROACH IN RP-HPLC METHOD DEVELOPMENT FOR QUANTIFICATION OF LAMIVUDINE AND EFFAVIRENZ IN COMBINATION FORMULATION

Bhagavan Rajesh Babu Koppisetty; Prof. Y. Rajendra Prasad; Krishna Manjari Pawar Amgoth; Srinivasa Rao Yarraguntla; Vasudha Dadı; Hemant Kumar Tatapudı

Makale detayları

UTILITY OF QUALITY BY DESIGN APPROACH IN RP-HPLC METHOD DEVELOPMENT FOR QUANTIFICATION OF LAMIVUDINE AND EFFAVIRENZ IN COMBINATION FORMULATION

Yazarlar:

Bhagavan Rajesh Babu Koppisetty | Prof. Y. Rajendra Prasad | Krishna Manjari Pawar Amgoth | Srinivasa Rao Yarraguntla | Vasudha Dadı | Hemant Kumar Tatapudı

Yayıncı:

Ankara University

Ana Başlıklar:

Eczacılık ve İlaç Bilimleri

Dergi:

Ankara Üniversitesi Eczacılık Fakültesi Dergisi Vol.47 Issue 2, pp.625-636

Belge Tipi:

Makale

Yayın Tarihi:

5/2023

Belge Dili:

İngilizce

Document ID (Org No.):

2001282812

pISSN:

1015-3918

Anahtar kelimeler:

Özet:

 Objective: For the measurement of lamivudineLAM and effavirenz EVZ in combination formulation, an uncomplicated and reliable liquid chromatographic approach has been proposed. Material and Method: The design of experiments DoE was used to set up the experimental conditions for the multivariate optimization of the RP-HPLC method. The crucial method parameters were determined by a risk assessment. The mathematical models were created using three independent variables: percentage of acetonitrile, percentage of methanol, and buffer pH. The impacts of these independent elements were thoroughly investigated using the central composite design CCD, which was utilized to analyze the response surface methodology. Result and Discussion: The LAM and EVZ retention time and resolution were both concurrently optimized using the desirability function. Acetonitrile, methanol, and phosphate buffer pH 7.0 in the proportions of 40:20:40 vv each were used in the optimized and anticipated data from the contour diagram, with detection occurring at a wavelength of 215 nm. Baseline separation of both pharmaceuticals with high resolution and a run time of under 6 minutes was accomplished under these ideal conditions. The validated test parameters followed ICH recommendations. As a consequence, the findings demonstrated that the Quality by Design methodology could be successfully used to optimize the RP-HPLC technique for the concurrent quantification of LAM and EVZ.

 Objective: For the measurement of lamivudineLAM and effavirenz EVZ in combination formulation, an uncomplicated and reliable liquid chromatographic approach has been proposed. Material and Method: The design of experiments DoE was used to set up the experimental conditions for the multivariate optimization of the RP-HPLC method. The crucial method parameters were determined by a risk assessment. The mathematical models were created using three independent variables: percentage of acetonitrile, percentage of methanol, and buffer pH. The impacts of these independent elements were thoroughly investigated using the central composite design CCD, which was utilized to analyze the response surface methodology. Result and Discussion: The LAM and EVZ retention time and resolution were both concurrently optimized using the desirability function. Acetonitrile, methanol, and phosphate buffer pH 7.0 in the proportions of 40:20:40 vv each were used in the optimized and anticipated data from the contour diagram, with detection occurring at a wavelength of 215 nm. Baseline separation of both pharmaceuticals with high resolution and a run time of under 6 minutes was accomplished under these ideal conditions. The validated test parameters followed ICH recommendations. As a consequence, the findings demonstrated that the Quality by Design methodology could be successfully used to optimize the RP-HPLC technique for the concurrent quantification of LAM and EVZ.

 Objective: For the measurement of lamivudineLAM and effavirenz EVZ in combination formulation, an uncomplicated and reliable liquid chromatographic approach has been proposed. Material and Method: The design of experiments DoE was used to set up the experimental conditions for the multivariate optimization of the RP-HPLC method. The crucial method parameters were determined by a risk assessment. The mathematical models were created using three independent variables: percentage of acetonitrile, percentage of methanol, and buffer pH. The impacts of these independent elements were thoroughly investigated using the central composite design CCD, which was utilized to analyze the response surface methodology. Result and Discussion: The LAM and EVZ retention time and resolution were both concurrently optimized using the desirability function. Acetonitrile, methanol, and phosphate buffer pH 7.0 in the proportions of 40:20:40 vv each were used in the optimized and anticipated data from the contour diagram, with detection occurring at a wavelength of 215 nm. Baseline separation of both pharmaceuticals with high resolution and a run time of under 6 minutes was accomplished under these ideal conditions. The validated test parameters followed ICH recommendations. As a consequence, the findings demonstrated that the Quality by Design methodology could be successfully used to optimize the RP-HPLC technique for the concurrent quantification of LAM and EVZ.

 Amaç: Kombinasyon formülasyonunda lamivudin LAM ve effavirenzin EVZ ölçümü için karmaşık olmayan ve güvenilir bir sıvı kromatografik yaklaşım önerilmiştir. Gereç ve Yöntem: Deney tasarımı DoE, RP-HPLC yönteminin çok değişkenli optimizasyonu için deneysel koşulları ayarlamak üzere kullanıldı. RP-HPLC yönteminin çok değişkenli optimizasyonu, deneysel koşullar, deney tasarımı DoE kullanılarak gerçekleştirildi. Kritik yöntem parametreleri bir risk değerlendirmesi ile belirlendi. Matematiksel modeller üç bağımsız değişken kullanılarak oluşturulmuştur: asetonitril yüzdesi, metanol yüzdesi ve tampon pHı. Bu bağımsız öğelerin etkileri, yanıt yüzeyi metodolojisini analiz etmek için kullanılan merkezi bileşik tasarım CCD kullanılarak ayrıntılı bir şekilde incelenmiştir. Sonuç ve Tartışma: LAM ve EVZ tutma süresi ve çözünürlüğü, arzu edilebilirlik işlevi kullanılarak aynı anda optimize edildi. Her biri 40:20:40 vv oranlarındaki asetonitril, metanol ve fosfat tamponu pH 7.0, 215 nmlik bir dalga boyunda meydana gelen algılama ile kontur diyagramından optimize edilmiş ve beklenen verilerde kullanılmıştır. Her iki farmasötik maddenin yüksek çözünürlükte ve 6 dakikanın altında çalışma süresiyle temel ayrımı, bu ideal koşullar altında gerçekleştirildi. Doğrulanmış test parametreleri, ICH önerilerini izledi. Sonuç olarak, bulgular Tasarıma Göre Kalite metodolojisinin LAM ve EVZnin eş zamanlı ölçümü için RP-HPLC tekniğini optimize etmek üzere başarılı bir şekilde kullanılabileceğini göstermiştir.

Makale detayları

UTILITY OF QUALITY BY DESIGN APPROACH IN RP-HPLC METHOD DEVELOPMENT FOR QUANTIFICATION OF LAMIVUDINE AND EFFAVIRENZ IN COMBINATION FORMULATION

Yazarlar:

Bhagavan Rajesh Babu Koppisetty | Prof. Y. Rajendra Prasad | Krishna Manjari Pawar Amgoth | Srinivasa Rao Yarraguntla | Vasudha Dadı | Hemant Kumar Tatapudı

Yayıncı:

Ankara University

Ana Başlıklar:

Eczacılık ve İlaç Bilimleri

Dergi:

Ankara Üniversitesi Eczacılık Fakültesi Dergisi Vol.47 Issue 2, pp.625-636

Belge Tipi:

Makale

Yayın Tarihi:

5/2023

Belge Dili:

İngilizce

Document ID (Org No.):

2001282812

pISSN:

1015-3918

Central composite design

effavirenz

lamivudine

quality by design

RP-HPLC

Effavirenz

lamivudin

merkezi kompozit tasarım

RP-HPLC

tasarıma göre kalite

Sayı

Makale detayları

Yazarlar: Bhagavan Rajesh Babu Koppisetty | Prof. Y. Rajendra Prasad | Krishna Manjari Pawar Amgoth | Srinivasa Rao Yarraguntla | Vasudha Dadı | Hemant Kumar Tatapudı

Yayıncı: Ankara University

Ana Başlıklar: Eczacılık ve İlaç Bilimleri

Dergi: Ankara Üniversitesi Eczacılık Fakültesi Dergisi Vol.47 Issue 2, pp.625-636

Belge Tipi: Makale

Yayın Tarihi: 5/2023

Belge Dili: İngilizce

Document ID (Org No.): 2001282812

pISSN: 1015-3918

Sayı

Yazarlar:

Bhagavan Rajesh Babu Koppisetty | Prof. Y. Rajendra Prasad | Krishna Manjari Pawar Amgoth | Srinivasa Rao Yarraguntla | Vasudha Dadı | Hemant Kumar Tatapudı

Yayıncı:

Ankara University

Ana Başlıklar:

Eczacılık ve İlaç Bilimleri

Dergi:

Ankara Üniversitesi Eczacılık Fakültesi Dergisi Vol.47 Issue 2, pp.625-636

Belge Tipi:

Makale

Yayın Tarihi:

5/2023

Belge Dili:

İngilizce

Document ID (Org No.):

2001282812

pISSN:

1015-3918