ISSN

0974-4150 (Online)
0974-4169 (Print)


Author(s): Rajan V. Rele, Sandip P. Patil

Email(s): drvinraj@gmail.com

DOI: 10.52711/0974-4150.2021.00045   

Address: Rajan V. Rele*, Sandip P. Patil
Central Research Laboratory, D.G. Ruparel College, Matunga, Mumbai 400016.
*Corresponding Author

Published In:   Volume - 14,      Issue - 4,     Year - 2021


ABSTRACT:
A Novel Reverse Phase Liquid Chromatographic Method was developed and validated for estimation of metformin hydrochloride in its dosage form i.e. tablets. The reverse phase HPLC analysis was carried out on isocratic system. The column was Hypersil BDS C18 (150mm x 4.6mm, 5µm) with ambient temperature. The mobile phase consisted of buffer: methanol in proportion 90:10 % (v/v). The flow rate was maintained at 1.0ml/ min. The detection was carried out at wavelength 230nm. The method was validated as per ICH guidelines for system suitability, linearity, accuracy and precision. The linear ranges were 50-150µg/ml for metformin hydrochloride, The accuracy and precision were found to be well within the acceptable limit. The method was successfully applied for determination Metformin hydrochloride in dosage form with good recoveries.


Cite this article:
Rajan V. Rele, Sandip P. Patil. Application of RP-HPLC Technique for development of Analytical method for Validation of Metformin hydrochloride from Bulk drug and Dosage form. Asian Journal of Research in Chemistry. 2021; 14(4):265-8. doi: 10.52711/0974-4150.2021.00045

Cite(Electronic):
Rajan V. Rele, Sandip P. Patil. Application of RP-HPLC Technique for development of Analytical method for Validation of Metformin hydrochloride from Bulk drug and Dosage form. Asian Journal of Research in Chemistry. 2021; 14(4):265-8. doi: 10.52711/0974-4150.2021.00045   Available on: https://ajrconline.org/AbstractView.aspx?PID=2021-14-4-6


REFERENCES:
1.    The United States Pharmacopeia. United States Pharmacopeia Convention Inc, Rockville, USP 35 NF 30; 2012.
2.    P Umapathi, J. Ayyappan and S Darlin Quine. Quantitative Determination of Metformin Hydrochloride in Tablet Formulation Containing Croscarmellose Sodium as Disintegrant by HPLC and UV Spectrophotometry, Tropical Journal of Pharmaceutical Research, 11(1); 2012,: 107-116.
3.    Himal PaudelChhetri, PannaThapa and AnnVan Schepdael. Simple HPLC-UV method for the quantification of metformin in human plasma with one step protein precipitation, Saudi Pharmaceutical Journal, 22(5); 2014: 483-487.
4.    Mousumi Kar and P. K. Chaudhury. HPLC Method for Estimation of Metformin Hydrochloride in Formulated Microspheres and Tablet Dosage Form. Indian Journal of pharmaceutical Sciences, 71(3); 2009: 318-320.
5.    Florentin TACHE and Monica ALBU. Specificity of an analytical HPLC assay method of metformin hydrochloride, Revue Roumaine de Chimie, 52(7); 2007: 603-609.
6.    K.S. Lakshmi, T. Rajesh, Shrinivas Sharma, Simultaneous determination of metformin and pioglitazone by reversed phase HPLC in pharmaceutical dosage forms, International Journal of Pharmacy and Pharmaceutical Sciences,1(2); 2009: 162-166.
7.    Mohammed sayeed arayane, najama sultana and hashim zuberi, Development and validation of RP-HPLC method for analysis of metformin, Pakistan Journal of Pharmaceutical sciences, 19(3); 2006: 231-235.
8.    Maria-cristina ranetti, Mihaela ionescu, Lavinia hinescu, Elena ionică, Valentina anuţa, Aurelian E. ranetti, Camelia elena stecoza, Constantin mircioiu. Validation of a HPLC method for the simultaneous analysis of metformin and gliclazide in human plasma, Farmacia, 57(6); 2009: 728-735.
9.    Fernanda Cristina Stenger, Luciana Catia Block, Rogerio Correa, Rilton Alves de Freitas and Tania Mari Belle Bresolin. HPLC Stability Indicating Assay Method for Metformin Hydrochloride in Bulk Drug and Tablets and Cytotoxicity of Degradation Products, Current Pharmaceutical Analysis, 8(4); 2012: 368-374.
10.    Murthy TGK and Geethanjali J. Development of a Validated RP-HPLC Method for Simultaneous Estimation of Metformin Hydrochloride and Rosuvastatin Calcium in Bulk and In-House Formulation, Journal of Chromatography Separation Techniques, 5(6); 2014: 1-7.
11.    Gadapa Nirupa and Upendra M. Tripathi, RP-HPLC analytical method development and validation for simultaneous estimation of three drugs: Glimepiride, Pioglitazone and Metformin and Its Pharmaceutical Dosage Forms, Journal of Chemistry, 2013: 1-8.
12.    Battula sreenivasa rao, Som shankar dubey, K. Nagendar rao and B. Venkata kiran, Development and Validation of A Reverse Phase HPLC Method for the Determination of Metformin HCl in Pharmaceutical Dosage Forms, Asian Journal of Chemistry, 24(12); 2012: 5460-5462.
13.    A.A. Sakalgaonkar, S.R. Mirgane and B.R. Arbad, Validated high performance liquid chromatographic stability indicating method for the analysis of metformin HCl, International Journal of applied Environmental Science 3(2); 2008: 169-176
14.    T Sudha, Vamsi Krishna and VR RaviKumar, A Validated Stability Indicating Reverse Phase Liquid Chromatography Method for Metformin HCl and its Impurities in Bulk and Pharmaceutical Dosage Form, Research and reviews: Journal of Pharmaceutical Analysis, 3(1); 2014: 27-33.
15.    Sena Caglar and Ali Rahmi Alp. A Validated High Performance Liquid Chromatography Method for the Determination of Saxagliptin and Metformin in Bulk, a Stability Indicating Study, Journal of Analytical and Bioanalytical Techniques, 12; 2014: 1-5.
16.    Rajan V. Rele, Sandip P. Patil, Identification, Isolation and Characterization of unknown Impurity in Metformin hydrochloride, IOSR Journal of Pharmacy, 8(7); 2018:6-11.

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