A NEW AND RAPID ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS ESTIMATION OF METFORMIN, PIOGLITAZONE AND GLIMEPRIDE IN TABLET DOSAGE FORM BY USING UPLC
Journal Title: International Research Journal of Pharmacy (IRJP) - Year 2014, Vol 5, Issue 4
Abstract
The present work was undertaken with the aim to develop and validate a rapid and consistent UPLC method in which the peaks will be appear with short period of time as per ICH Guidelines. The proposed method was simple, fast, accurate and precise method for the Quantification of drug in the dosage form, bulk drug as well as for routine analysis in Quality control. UPLC method was developed and validated for simultaneous estimation of Metformin, Pioglitazone and Glimepiride in bulk drug and in combined dosage forms. The UPLC separation was achieved on a Symmetry C18 (2.1 x 100 mm, 1.7 m, Make: BEH) or equivalent in an Isocratic Mode. The mobile phase was composed of Phosphate Buffer (25 %) whose pH was adjusted to 4.3 by using Ortho Phosphoric Acid and Methanol (75 %) [UPLC Grade] The flow rate was monitored at 0.25 ml per min. The wavelength was selected for the detection was 258 nm. The run time was 5 minutes. The retention time found for the drugs Metformin, Pioglitazone and Glimepiride were 0.002 minutes, 1.773 minutes and 2.409 minutes respectively. The % recovery was found to be 99.7 % - 100.9 % for the drug Metformin. The % recovery was found to be 98.4 % - 100.9 % for the drug Pioglitazone. The % recovery was found to be 99.9 % - 101.2 % for the drug Glimepiride. The linearity was established in the range of 400 to 600 ppm for the drug Metformin and 12 to18 ppm for the drug Pioglitazone and 0.8 to 1.2 ppm for the drug Glimepiride. The LOD for the drugs Metformin, Pioglitazone and Glimepiride were found to be 0.12 µg/ml, 0.002 µg/ml and 0.002 µg/ml respectively. The LOQ for the drugs Metformin, Pioglitazone and Glimepiride were found to be 0.45 µg/ml, 0.15 µg/ml and 0.08 µg/ml respectively. The proposed method was adequate sensitive, reproducible, and specific for the determination of Metformin, Pioglitazone and Glimepiride in bulk as well as in Tablet dosage form. The validation of method was carried out utilizing ICH-guidelines. The described UPLC method was successfully employed for the analysis of pharmaceutical formulations containing combined dosage form. Overall the proposed method was found to be suitable and accurate for the Quantitative determination of the drug in Tablet dosage form. The method was simple, precise, accurate and sensitive and applicable for the simultaneous determination of Metformin, Pioglitazone and Glimepiride in bulk drug and in combined dosage forms.
Authors and Affiliations
G. Sravan Reddy, S. Ashutosh Kumar, V. Raj Kumar
Keywords
Related Articles
- EP ID EP104907
- DOI 10.7897/2230-8407.050461
- Views 105
- Downloads 0
PULSATILE DRUG DELIVERY SYSTEM: A REVIEW
The purpose for this review on pulsatile drug delivery systems (PDDS) is to compile the recent literatures with special focus on the different types and approaches involved in the development of the formulation. Pulsatil...
IMPROVEMENT OF SOLUBILITY AND DISSOLUTION RATE OF MEFENAMIC ACID BY SOLID DISPERSIONS IN PEG4000
The aim of this study was to prepare and characterize solid dispersions of water insoluble non-steroidal anti-inflammatory drug, mefenamic acid (MA), with polyethylene glycol 4000 (PEG4000) for enhancing the dissolution...
SYNTHESIS AND EVALUATION OF ANTIMICROBIAL ACTIVITY OF 1-BENZOYL-1H-PYRAZOLO [4,3-C]QUINOLIN-4(5H)-ONES
A series of 1-benzoyl-1H-pyrazolo [4,3-C]quinolin-4(5H)-one, carrying appropriate substituents at the Quinoline ring have been synthesized in good yields via the condensation of 4-chloro-3-formylquinolin-2[1H]ones with b...
SIGNALLING PATHWAY OF NADPH MEDIATED ROS-RNS IN DIABETIC NEPHROPATHY
Disorder of physiological signaling functions of reactive oxygen species (ROS) superoxide (ROS are chemically reactive molecules containing oxygen), hydrogen peroxide, reactive nitrogen species (RNS) nitric oxide and per...
ANALYSIS OF INFLUENCE OF MARKETING ON SALE OF AYURVEDIC DRUGS
In India, there are more than 700 Ayurvedic hospitals with more than 35,000 beds and 435,000 Ayurvedic physicians. This makes treatments and product prescriptions more readily accessible and widespread acceptance of Ayur...