Afroz Patan, Syed Reeyaz Basha, Ravi Kumar Ketha, Binoy Vargheese Cheriyan, Vijey Aanandhi Muthukumar
Afroz Patan*, Syed Reeyaz Basha, Ravi Kumar Ketha, Binoy Vargheese Cheriyan, Vijey Aanandhi Muthukumar
Department of Pharmaceutical Chemistry and Analysis, School of Pharmaceutical Sciences, Vels Institute of Sciences, Technology and Advanced Studies (VISTAS), Pallavaram, Chennai – 603117, Tamilnadu, India.
Volume - 14,
Issue - 3,
Year - 2021
Objective: A simple, accurate, precise, new RP-HPLC method was developed and validated for the determination of Metformin hydrochloride and Repaglinide in bulk and its pharmaceutical formulations. Method: The literature survey reveals that good analytical methods are not available for simultaneous estimation of drugs like Metformin hydrochloride and Repaglinide, which suffer from major disadvantage such as low sensitivity, lack of selectivity and simplicity. The existing physicochemical methods are inadequate to meet the requirements; hence a new RP-HPLC method has been developed for simultaneous estimation of Metformin hydrochloride and Repaglinide in bulk and its pharmaceutical formulations. A XBridge C18 (4.6 x 150mm, 3.5 ?m, Make: Waters) or equivalent in an isocratic mode with mobile phase Potassium dihyrogen ortho phosphate (2.2 pH): Acetonitrile (35:65%v/v) was used. The flow rate was 0.6ml/ min and effluent was monitored at 240 nm. The retention time of Metformin hydrochloride and Repaglinide was 2.517 and 3.825 min. The linearity range was found to be 5-50?g/ml. The proposed method was validated statistically. Tablets of Metformin hydrochloride and Repaglinide [500.0mg and 2.0mg] was formulated in the lab scale for estimation by the developed method. Results: The method developed was approved for various parameters like accuracy, specificity, precision, range, linearity, robustness, LOD, LOQ and system suitability according to ICH guidelines. The results got were according the acceptance criteria. Conclusion: The sample recoveries in the formulation were in good agreement with their respective label claims and no interference of formulation excipients in the estimation. The technique could be easily and conveniently adopted for routine analysis of Zolpidem Tartrate in pure form and its dosage form and also for dissolution or similar studies.
Cite this article:
Afroz Patan, Syed Reeyaz Basha, Ravi Kumar Ketha, Binoy Vargheese Cheriyan, Vijey Aanandhi Muthukumar. Development and Validation of New RP- HPLC Method for the Simultaneous Estimation of Metformin Hydrochloride and Repaglinide in Pure and Pharmaceutical Formulations. Research J. Pharm. and Tech 2021; 14(3):1323-1328. doi: 10.5958/0974-360X.2021.00235.3
1. Al- Rimawi F, Talanta. Development and validation of an analytical method for metformin hydrochloride and its related compound (1-cyanoguanidine) in tablet formulations by HPLC-UV, 2009; 79(5): 1368-71.
2. M Saeed Arayne, Najma Sultana, M Hashim Zuberi. Development and validation of RP-HPLC method for the analysis of metformin, Pakistan Journal Of Pharmaceutical Sciences, 2006; 19(3): 231-235.
3. Mousumi Kar, P K ChoudhurY. HPLC Method for Estimation of Metformin Hydrochloride in Formulated Microspheres and Tablet Dosage Form, Indian Journal of Pharmaceutical Sciences, 2009; 71(3): 318-320.
4. Indy A, Nassar MW, El-Abasawy NM, Attia KA, Al-Shabrawi M. Optimization and validation of an RP-HPLC method for direct determination of metformin hydrochloride in human urine and in a dosage form, J AOAC Int, 2010 ; 93(6):1821-8.
5. Wang LR, Huang MZ, Zhu SH, Zhejiang Da Xue Xue Bao Yi Xue Ban. HPLC determination of metformin hydrochloride-related substances. 2005; 34(4): 368-71.
6. Florentin Tache and Monica Albu, Revue Roumaine de Chimie, Specificity of an analytical HPLC assay method of metformin hydrochloride. 2007; 52(6): 603–609.
7. H.H. Gadape and K.S. Parikh. Quantitative Determination and Validation of Metformin Hydrochloride in Pharmaceutical Using Quantitative Nuclear Magnetic Resonance Spectroscopy. E-Journal of Chemistry, 2011; 8(2):767-781.
8. JR Patel, BN Suhagia, BH Patel. Simultaneous spectrophotometric estimation of metformin and repaglinide in a synthetic mixture, International Journal of Pharmaceutical Sciences, 2007; 69(6): 844-846.
9. Meeta A. Jiladia, S. S. Pandya, Ashok G. Jiladia. High Performance Liquid Chromatographic Method for Estimation of Repaglinide in Tablet Dosage Forms International Journal of Pharma and Bio Sciences, 2010; 1(2) 767-781.
10. Prameela Rani. A, Bala Sekaran. C, Archana. N, Siva Teja. P, Aruna. Determination of Repaglinide in Pharmaceutical Formulations by RP-HPLC Method, Journal of Applied Sciences Research, 2009; 5(10):1500-1504.
11. Ruzilawati AB, Wahab MS, Imran A, Ismail Z, Gan SH. Method development and validation of repaglinide in human plasma by HPLC and its application in pharmacokinetic studies, 2007; 43(5); 1831-5.
12. Dash Arun Kumar, Pradhan Kishanta Kumar, Dash Ranjita, Murthy P.N. Palo Amitesh Kumar. Method development, validation and stability study of repaglinide in bulk and pharmaceutical dosage form by UV spectrometric method, International Journal of Biological and Pharmaceutical Research 2011; 2(1): 7-10.
13. Deepa R. Patel, Laxmanbhai J. Patel, Madhabhai M. Patel. Development and Validation of stability indicating method for the determination of Repaglinide in Pharmaceutical dosage form using High Performance Liquid Chromatography. International Journal of ChemTech Research. 2011; 3(2), 539-546.
14. Mukesh Chandra Sharma, Smita Sharma. Stability Indicating RP-HPLC Method for Determination and Validation of Repaglinide in Pharmaceutical Dosage Form. International Journal of ChemTech Research. 2011; 3(1): 210-216.