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Gandhi, Tejal R.
- Development and Evaluation of Robust RP-HPLC Method for Gliclazide Estimation Integrating Box Behnken Design
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Authors
Mansi S. Dholakia
1,
Hardik B. Rana
2,
Saloni Desai
2,
Mukesh C. Gohel
2,
Kalpana G. Patel
2,
Vaishali T. Thakkar
2,
Tejal R. Gandhi
2
Affiliations
1 Dharamsinh Desai University, Nadiad- 387001, Gujarat, IN
2 Department of Pharmaceutics, Anand Pharmacy College, Anand - 388 001, Gujarat, IN
1 Dharamsinh Desai University, Nadiad- 387001, Gujarat, IN
2 Department of Pharmaceutics, Anand Pharmacy College, Anand - 388 001, Gujarat, IN
Source
Research Journal of Pharmacy and Technology, Vol 12, No 1 (2019), Pagination: 135-141Abstract
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
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- Vulnerability of Hydro-Alcoholic Media on In Vitro Drug Release from Galantamine HBr Pellets Comprising of Compritol 888 ATO and Ethocel
Abstract Views :169 |
PDF Views:0
Authors
Hardik B. Rana
1,
Mukesh C. Gohel
1,
Mansi S. Dholakia
2,
Tejal R. Gandhi
,
Abdelwahab Omri
3,
Vaishali T. Thakkar
1
Affiliations
1 Department of Pharmaceutics, Anand Pharmacy College, Anand - 388001, Gujarat, IN
2 Institute of Pharmacy, Dharmasinh Desai University, Nadiad - 387001, Gujarat, IN
3 The Novel Drug and Vaccine Delivery Systems Facility, Department of Chemistry and Biochemistry, Laurentian University, Sudbury, ON, CA
1 Department of Pharmaceutics, Anand Pharmacy College, Anand - 388001, Gujarat, IN
2 Institute of Pharmacy, Dharmasinh Desai University, Nadiad - 387001, Gujarat, IN
3 The Novel Drug and Vaccine Delivery Systems Facility, Department of Chemistry and Biochemistry, Laurentian University, Sudbury, ON, CA
Source
Research Journal of Pharmacy and Technology, Vol 12, No 2 (2019), Pagination: 791-798Abstract
Objective: The objective of the present study was to assess the interaction between the Galantamine HBr pellets and alcohol. Concomitant administration of alcohol and formulation can affect the plasma concentration of drug or give dose dumping effect or failure of the dosage form as the number of excipients especially polymers used in the modified dosage form cannot withstand in the presence of alcohol. Materials and Methods: The modified release pellets of galantamine hydrobromide were formulated incorporating a waxy polymer – Compritol 888 ATO and a hydrophobic polymer – Ethocel using extrusion spheronization technique. In vitro drug release of galntamine pellets was performed in distilled water and 10-40% ethanol containing distilled water. The saturated solubility of galantamine was measured in different dissolution media and pure ethanol. Results and Discussion: In vitro drug release study showed similarity at all the levels of alcohol (10-40%) as f2 value was found to be more than 50. In vitro drug release was slightly reduced in the presence of alcohol as the galantamine is slightly less soluble in ethanol compared to distilled water. There was change observed in drug release kinetics and mechanism but no significant change was observed in drug release. Conclusion: The suitability of Compritol 888 ATO and Ethocel as a matrix forming excipient in the formulation of pellets can resist the effect of alcohol makes it suitable for the alternative polymer in the wider application for designing of modified release dosage form.Keywords
Hydroalcoholic Media, Compritol 888 ATO, Ethocel, Sustained Release Pellets, Galantamine HBrReferences
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