Research Journal of Pharmacy and Technology

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Development and Evaluation of Robust RP-HPLC Method for Gliclazide Estimation Integrating Box Behnken Design


Affiliations
1 Dharamsinh Desai University, Nadiad- 387001, Gujarat, India
2 Department of Pharmaceutics, Anand Pharmacy College, Anand - 388 001, Gujarat, India
     

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A selective, precise and accurate RP-HPLC method was developed and validated for rapidly determining the quantity of gliclazide in pharmaceutical dosage form. Isocratic elution was employed on a PhenomenexC18 column at a flow rate of 1.2 ml/min. The mobile phase consisted of methanol and 0.02 M potassium dihydrogen orthophosphate (70:30 %v/v). Gliclazide was detected at 210 nm wavelength using UV detector. Linearity was observed in concentration range of 1-100 μg/ml. Retention time of gliclazide retention time was found to be 6.06 min. Validation of developed method was performed as per the ICH guideline. Experimental design approach was used for confirmation of robustness by using Box-Behnken Design with a total 17 runs. The newer method is found to be promising for the estimation of gliclazide in unit or bulk pharmaceutical dosage form.

Keywords

Gliclazide, RP-HPLC, Validation, Box-Behnken Design, Robustness.
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  • Development and Evaluation of Robust RP-HPLC Method for Gliclazide Estimation Integrating Box Behnken Design

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Authors

Mansi S. Dholakia
Dharamsinh Desai University, Nadiad- 387001, Gujarat, India
Hardik B. Rana
Department of Pharmaceutics, Anand Pharmacy College, Anand - 388 001, Gujarat, India
Saloni Desai
Department of Pharmaceutics, Anand Pharmacy College, Anand - 388 001, Gujarat, India
Mukesh C. Gohel
Department of Pharmaceutics, Anand Pharmacy College, Anand - 388 001, Gujarat, India
Kalpana G. Patel
Department of Pharmaceutics, Anand Pharmacy College, Anand - 388 001, Gujarat, India
Vaishali T. Thakkar
Department of Pharmaceutics, Anand Pharmacy College, Anand - 388 001, Gujarat, India
Tejal R. Gandhi
Department of Pharmaceutics, Anand Pharmacy College, Anand - 388 001, Gujarat, India

Abstract


A selective, precise and accurate RP-HPLC method was developed and validated for rapidly determining the quantity of gliclazide in pharmaceutical dosage form. Isocratic elution was employed on a PhenomenexC18 column at a flow rate of 1.2 ml/min. The mobile phase consisted of methanol and 0.02 M potassium dihydrogen orthophosphate (70:30 %v/v). Gliclazide was detected at 210 nm wavelength using UV detector. Linearity was observed in concentration range of 1-100 μg/ml. Retention time of gliclazide retention time was found to be 6.06 min. Validation of developed method was performed as per the ICH guideline. Experimental design approach was used for confirmation of robustness by using Box-Behnken Design with a total 17 runs. The newer method is found to be promising for the estimation of gliclazide in unit or bulk pharmaceutical dosage form.

Keywords


Gliclazide, RP-HPLC, Validation, Box-Behnken Design, Robustness.

References