Author(s): K. Naga Prashant, A. Vijaya Lakshmi

Email(s): Email ID Not Available

DOI: 10.5958/0974-360X.2020.00932.4   

Address: K. Naga Prashant, A. Vijaya Lakshmi*
Department of Pharmacognosy, School of Pharmaceutical Sciences, Vels Institute of Science, Technology and Advanced Studies, Pallavaram, Chennai – 600117, Tamil Nadu, India.
*Corresponding Author

Published In:   Volume - 13,      Issue - 11,     Year - 2020


ABSTRACT:
A simple and precise liquid chromatography coupled with mass spectrometry LC-MS method was developed for determination and quantification of Drotaverine in human plasma and validated. The drug was separated by using liquid – liquid extraction (LLE) Method. A C18 column was employed for the separation of the drug on a gradient mode by using high-performance liquid chromatography (HPLC). The lower limit of quantification (LLOQ) of Drotaverine was 1.013ng/mL. The calibration curve ranges from of 0.993ng/mL to 498.245ng/mL with desirable linearity and r2 greater than 0.99. The intra-day accuracy was within 100.583–98.033% with coefficient of variation 0.90–0.14%. No significant interference observed by endogenous peak at the retention time of Drotaverine and IS. The assay was free from any matrix effect, precise recovery across the calibration curve range and samples were stable under all experimental conditions.


Cite this article:
K. Naga Prashant, A. Vijaya Lakshmi. A Validated Reverse Phase LC-MS Method for quantification of drotaverine in Biological matrices. Research J. Pharm. and Tech. 2020; 13(11):5333-5338. doi: 10.5958/0974-360X.2020.00932.4


REFERENCES:
1.    Chitlange SS, Ranjana S, Wankhede SB, Kulkarni AA. Spectrophotometric methods for simultaneous estimation of nimesulide and drotaverine. Intern. J of Chem Tech Research 2009; 1: 135-138.
2.    Sethi SD. Textbook of Pharmacology. Elsevier, New Delhi (2004) 831-40.
3.    Rai RR, Dwivedi M, Kumar N. Efficacy and safety of drotaverine hydrochloride in irritable bowel syndrome: a randomized double-blind placebo-controlled study. Saudi J Gastroenterol. 2014;20(6):378-82.
4.    Martindale, The Extra Pharmacopoeia, The Complete Drug Reference, 33rd Ed., Pharmaceutical Press, 2002, 51, 76, 1606.
5.    Abdellatef HE, Ayad MM, Soliman SM, Youssef NF. Spectrophotometric and spectrodensitometric determination of paracetamol and drotaverine HCl in combination. Spectrochimica acta. Part A, Molecular and Biomolecular Spectroscopy 2007; 66: 1147-1151.
6.    Metwally FH. Simultaneous determination of nifuroxazide and drotaverine hydrochloride in pharmaceutical preparations by bivariate and multivariate spectral analysis. Spectrochimica Acta. Part A, Molecular and Biomolecular Spectroscopy 2008; 69: 343-349.
7.    Dahivelkar PP, Mahajan VK, Bari SB, Shirkhedkar AA, Fursule RA, Surana SJ. Simultaneous derivative and multicomponent Spectrophotometric determination of drotaverine hydrochloride and mefenamic acid in tablets. Indian J of Pharm Sci 2007; 69: 812-814.
8.    Bolaji OO, Onyeji CO, Ogungbamila FO, Ogunbona FA, Ogunlana EO. High-performance liquid chromatographic method for the determination of drotaverine in human plasma and urine. J. of Chromatogr: Biomed Appl 1993; 622: 93-97.
9.    Lalla JK, Shah MU, Jain MB, Sharma AH. Modified high performance liquid chromatographic method for analysis of drotaverine in human plasma. J. of Pharm. Biomed. Anal 1993; 11: 385-388.
10.    Mezei J, Kuttel S, Szentmiklosi P, Marton S, Racz I. A new method for high-perfromance liquid chromatographic determination of drotaverine in plasma. J. of Pharm Sci. 2006; 73: 1489 –1491.
11.    Ayad MM, Youssef NF, Abdellatif HE, Soliman SM. A comparative study on various spectrometries with thin layer chromatography for simultaneous analysis of drotaverine and nifuroxazide in capsules. Chemical and Pharma Bull 2006; 54: 6807.
12.    Metwally FH, Abdelkawy M, Naguib IA Determination of nifuroxazide and drotaverine hydrochloride in pharmaceutical preparations by three independent analytical methods. J. of AOAC Intern. 2006; 89: 78-87.(HPTLC, Spectro, HPLC)
13.    Ziyatdinova GK, Samigullin AI, Budnikov GK Voltammetric determination of papaverine and drotaverine. J. of Anal. Chem. 2007; 62: 773-776.
14.    Guidance for industry, bioanalytical method validation, US Department of Health and Human Services, Food and Drug Administration Centre for Drug Evaluation and Research (CDER), Centre for Veterinary Medicine (CVM), May 2001.
15.    Prasad P. Dahivelkar, Suvarna I. Bhoir, Sanjay B. Bari, Sanjay J. Surana, Ashok M. Bhagwat, Simultaneous Determination of Diclofenac Potassium and Drotaverine Hydrochloride in Human Plasma using Reversed-Phase High-Performance Liquid Chromatography, Journal of Chromatographic Science, Volume 50, Issue 8, September 2012, Pages 694–701.
16.    Dariusz Tomaszewski and Mariusz Bałkota, “Intramuscular Administration of Drotaverine Hydrochloride Decreases Both Incidence of Urinary Retention and Time to Micturition in Orthopedic Patients under Spinal Anesthesia: A Single Blinded Randomized Study,” BioMed Research International, Vol. 2015, Article ID 926953, 7 pages, 2015.

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