scholarly journals Application of Design of Experiment in Design, Development and Optimization of Stability Indicating RP-HPLC Method for Simultaneous Determination of Montelukast Sodium and Rupatadine Fumarate in Bulk and Formulation

2021 ◽  
pp. 126-144
Author(s):  
A. S. Sutar ◽  
C. S. Magdum
Keyword(s):  
Simultaneous Determination ◽  
Design Of Experiment ◽  
Method Development ◽  
Degradation Products ◽  
Design Development ◽  
Stability Indicating ◽  
Rp Hplc ◽  
Montelukast Sodium ◽  
Stress Degradation

Design of Experiment assisted stability indicating RP-HPLC wasdesigned, developed and optimized using response surface methodology for simultaneous determination of Montelukast sodium and Rupatadine fumarate. Separation was achieved using Acetonitrile: Phosphate buffer (75:25) v/v with pH adjusted to 4.0, flow rate of 1 ml/min with UV detection at 246 nm on RP-C18 column. Stress degradation studies were performed as per scientific guidelines. Method was validated in accordance with regulatory requirements. Results obtained in validation were found to be within specified limit. Montelukast was eluted at 3.99 min and Rupatadine was eluted at 13.25 min respectively. All stress degradation products are very well resolved from drug peak which indicate suitability indicating nature of the developed method. Design of Experiment technique can help in fast and economical optimization of mobile phase which in turn will save time for method development. The developed method is, accurate, sensitive which can be utilized as stability indicating method for identification of degradation products in routine analysis of the drug.

scholarly journals Application of Response Surface Methodology in Development and Optimization of Stability Indicating RP-HPLC Method for Determination of Tolvaptan in Bulk and Formulation

2021 ◽  
pp. 137-148
Author(s):  
A. S. Sutar ◽  
C. S. Magdum
Keyword(s):  
Response Surface Methodology ◽  
Response Surface ◽  
Design Of Experiment ◽  
Mobile Phase ◽  
Method Development ◽  
Degradation Products ◽  
Hplc Method ◽  
Stability Indicating ◽  
Rp Hplc

Design of Experiment assisted stability indicating RP-HPLC was developed and optimized using response surface methodology for determination of Tolvaptan.  Mobile phase was developed and optimized using Design of Experiment with response surface methodology. Acetonitrile and phosphate buffer with pH 5.5 (70:30% V/V) was optimized as mobile phase. The flow rate was maintained at 1ml/min. Stress studies were performed as per guidelines. Method was validated in accordance with regulatory requirements and results were within specified limits of regulatory guidelines. Tolvaptan was eluted at 3.24 min. It shows linearity from 2.5-15 µg/ml. Coefficient of correlation was 0.999, LOD and LOQ values were 1.0871 (µg/ml) and 3.2942 (µg/ml). Precision was determined with % RSD of 0.8669 and 0.9709%, mean percentage Recovery value was found to be 99.88 ±1.2. All stress degradation products are very well resolved from drug peak which indicate suitability indicating nature of the developed method. Design of Experiment technique can help in fast and economical optimization of mobile phase which inturn will save time for method development. The developed method is simple, accurate, sensitive which can be utilised as stability indicating method for identification of degradation products in routine analysis of the drug.

Stability-Indicating TLC-Densitometric and HPLC Methods for the Simultaneous Determination of Piracetam and Vincamine in the Presence of Their Degradation Products

2016 ◽  
Vol 99 (6) ◽  
pp. 1490-1498 ◽  
Author(s):  
Amal B Ahmed ◽  
Maha M Abdelrahman ◽  
Nada S Abdelwahab ◽  
Fathy M Salama
Keyword(s):  
Simultaneous Determination ◽  
Degradation Products ◽  
Hplc Method ◽  
Pharmaceutical Formulation ◽  
Stability Indicating ◽  
Rp Hplc ◽  
Accuracy And Precision ◽  
Array Detection ◽  
Assay Methods

Abstract Newly established TLC-densitometric and RP-HPLC methods were developed and validated for the simultaneous determination of Piracetam (PIR) and Vincamine (VINC) in their pharmaceutical formulation and in the presence of PIR and VINC degradation products, PD and VD, respectively. The proposed TLC-densitometric method is based on the separation and quantitation of the studied components using a developing system that consists of chloroform–methanol–glacial acetic acid–triethylamine (8 + 2 + 0.1 + 0.1, v/v/v/v) on TLC silica gel 60 F254 plates, followed by densitometric scanning at 230 nm. On the other hand, the developed RP-HPLC method is based on the separation of the studied components using an isocratic elution of 0.05 M KH2PO4 (containing 0.1% triethylamine adjusted to pH 3 with orthophosphoric acid)–methanol (95 + 5, v/v) on a C8 column at a flow rate of 1 mL/min with diode-array detection at 230 nm. The developed methods were validated according to International Conference on Harmonization guidelines and demonstrated good accuracy and precision. Moreover, the developed TLC-densitometric and RP-HPLC methods are suitable as stability-indicating assay methods for the simultaneous determination of PD and VD either in bulk powder or pharmaceutical formulation. The results were statistically compared with those obtained by the reported RP-HPLC method using t- and F-tests.

RP-HPLC method development for simultaneous determination of the drugs Ramipril and Amlodipine

2012 ◽  
Vol 2 (2) ◽  
pp. 364-367 ◽  
Author(s):  
Saida Naik Dheeravath ◽  
◽  
Kasani Ramadevi ◽  
Zilla Saraswathi ◽  
Dheeravath Maniklal ◽  
...  
Keyword(s):  
Simultaneous Determination ◽  
Method Development ◽  
Hplc Method ◽  
Rp Hplc ◽  
Hplc Method Development

Validated stability-indicating RP-HPLC UV method for simultaneous determination of metformin and repaglinide

2012 ◽  
Vol 24 (3) ◽  
pp. 419-432 ◽  
Author(s):  
S. S. Joshi ◽  
R. R. Nahire ◽  
N. R. Shastri ◽  
K. V. Surendranath ◽  
J. Satish
Keyword(s):  
Simultaneous Determination ◽  
Stability Indicating ◽  
Rp Hplc
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