Author(s): Narendra Kumar Pandey, Sachin Kumar Singh, Dipanjoy Ghosh, Rubiya Khursheed, Rajan Kumar, Bhupinder Kapoor, Bimlesh Kumar, Ankit Awasthi

Email(s): singhsachin23@gmail.com

DOI: 10.5958/0974-360X.2020.00300.5   

Address: Narendra Kumar Pandey, Sachin Kumar Singh*, Dipanjoy Ghosh, Rubiya Khursheed, Rajan Kumar, Bhupinder Kapoor, Bimlesh Kumar, Ankit Awasthi
School of Pharmaceutical Sciences, Lovely Professional University, Punjab-144411, India.
*Corresponding Author

Published In:   Volume - 13,      Issue - 4,     Year - 2020


ABSTRACT:
An analytical method was developed using reverse phase high performance liquid chromatograph (RP-HPLC) system and a C-18 reverse-phase column (Nucleodur C18, 250mm × 4.6mm i.d.,5µ) for simultaneous estimation of simvastatin and glimepiride. Acetonitrile and potassium dihydrogen phosphate buffer pH 4 (75:25, v/v) were used as mobile phase. The flow rate was 1 mL min-1 and the chromatogram of both drugs was detected at wavelength of 232 nm. Method was validated as per ICH Q2 (R1) guidelines. The retention times of glimepiride and simvastatin was found to be 4.726 min and 9.829 min, respectively. Both drugs have shown linearity over the concentration range 2-10µg/mL with r2 of 0.997 for GLM and 0.998 for SIM. The mean percentage recovery of both the drugs was found within 98-102% at all the levels which indicated that the method was accurate. The percentage relative standard deviation was found less than 2% which indicated that method was satisfactorily précised. The LOD and LOQ were found to be 0.24 and 0.73 for simvastatin and 0.32 and 0.96 for glimepiride. The method was found to be robust as there was no significant change in response with variation in pH, flow rate and mobile phase composition. It was concluded that the developed method has passed all the validation tests and can be successfully applied to estimate the presence of both the drugs in bulk as well as in pharmaceutical formulations.


Cite this article:
Narendra Kumar Pandey, Sachin Kumar Singh, Dipanjoy Ghosh, Rubiya Khursheed, Rajan Kumar, Bhupinder Kapoor, Bimlesh Kumar, Ankit Awasthi. Method Development and Validation for Simultaneous Estimation of Glimepiride and Simvastatin by using Reversed Phase High-performance Liquid Chromatography. Research J. Pharm. and Tech. 2020; 13(4): 1655-1659. doi: 10.5958/0974-360X.2020.00300.5


REFERENCES:
1.    Alakhali, K, Hassan, Y, Mohamed,  N, Mordi, MN. Pharmacokinetic of simvastatin study in Malaysian subjects. IOSR Journal of  Pharmacy 2013; 3:46-51.
2.    Yadav, SK, Mishra, S, Mishra, B. Eudragit-based nanosuspension of poorly water-soluble drug: formulation and in vitro–in vivo evaluation. AAPS PharmSciTech 2012; 13: 1031-44.
3.    Galani, VJ, Vyas, M. In vivo and in vitro drug interactions study of glimepride with atorvastatin and rosuvastatin. J Young Pharm 2010; 2: 196-200.
4.    Patrizia, G, Maria, CP, Giuseppina, G, Anna, MM, Elena, C, Simona, P, Antonietta, S, Chiara, L, and Maurizio, B. Pharmacological Actions of Statins: A Critical Appraisal in the Management of Cancer. Pharmacological Reviews 2012; 64: 106-46.

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