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 - 2,
Year - 2021
Objective: A simple, accurate, precise, Stability indicating new RP-HPLC method was developed and validated for Zolpidem tartrate in pure and pharmaceutical formulations. Method: The literature survey reveals that good analytical methods are not available for the drugs like Zolpidem Tartrate, 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 the assay of Zolpidem Tartrate in pure and pharmaceutical dosage forms. A Symmetry XTerra C18 (4.6 x 150mm, 5?m, Make: Waters) or equivalent in an isocratic mode with mobile phase Ammonium Acetate Buffer (pH 4.5): Methanol (40:60%v/v) was used. The flow rate was 0.8 ml/ min and effluent was monitored by UV/PDA detector at 300nm. The retention time of Zolpidem Tartrate was at 3.14 min. The linearity range was found to be 20-60?g/ml. The proposed method was validated statistically. 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, Validation and Stability indicating new RP-HPLC method for the Determination of Zolpidem tartrate in pure and Pharmaceutical Formulations. Research J. Pharm. and Tech. 2021; 14(2):757-762. doi: 10.5958/0974-360X.2021.00132.3
Afroz Patan, Syed Reeyaz Basha, Ravi Kumar Ketha, Binoy Vargheese Cheriyan, Vijey Aanandhi Muthukumar. Development, Validation and Stability indicating new RP-HPLC method for the Determination of Zolpidem tartrate in pure and Pharmaceutical Formulations. Research J. Pharm. and Tech. 2021; 14(2):757-762. doi: 10.5958/0974-360X.2021.00132.3 Available on: https://www.rjptonline.org/AbstractView.aspx?PID=2021-14-2-28
1. Ring PR, Bostick JM. Validation of a method for the determination of Zolpidem in human plasma using LC with fluorescence detection. J Pharma Biomed Anal. 2000; 22: 495-504.
2. Nirogi RV, Kandikere VN, Shrivasthava W, Mudigonda K. Quantification of Zolpidem tartrate in human plasma by high performance liquid chromatography with fluorescence detection. J Chromatography B. 2004; 811: 59-63.
3. Laviana L, Mangas C, Fernández-Mari F, Bayod M, Blanco D. Determination and in-process control of zolpidem synthesis by high-performance liquid chromatography. J Pharm Biomed Anal. 2004; 36(4):925-8.
4. Chomwal R, Amit K, Goyal A. Spectrophotometric methods for Determination of Zolpidem tartrate in tablet formulation. J Pharma Bioallied Sci. 2010; 2(4): 365-368.
5. Maharajan MP, Sawant SD. Validated RP-HPLC method for the Determination of Zolpidem tartrate in bulk and tablet dosage forms. Int J Pharm Pharm Sci. 2012; 4(5):268–274.
6. J Kim; S Lee, S In, H Choi, H Chung. Validation of a simultaneous analytical method for the detection of 27 benzodiazepines and metabolites and Zolpidem in hair using LC-MS/MS and its application to human and rat hair. J Chromatogr B Analyt Technol Biomed Life Sci. 2011; 879(13-14): 878-86.
7. Murthy MV, Krishnaiah C, Kumar R, Mukkanti K. Development of stability-indicating UPLC method for the determinining zolpidem tartrate and its product related variants in drug substance and drug products. J Liq Chromatogr Relat Technol. 2013;36: 836–851.
8. Ptacek P, Macek J, Klíma J. Rapid and simple method for the determination of zolpidem in human plasma by high-performance liquid chromatography. J Chromatogr B Biomed Sci Appl. 1997 694(2):409-13.
9. Kintz P, Villain M, Ludes B. Testing for zolpidem in oral fluid by liquid chromatography-tandem mass spectrometry. J Chromatogr B Analyt Technol Biomed Life Sci. 2004; 811(1):59-63.
10. Wang Q, Sun L, Lau CE. Determination of zolpidem in serum microsamples by high-performance liquid chromatography and its application to pharmacokinetics in rats. J Chromatogr B Biomed Sci Appl. 1999 Nov 12; 734(2):299-305.
11. Lalitha KG and Venkatachalam T. Simultaneous Estimation of Melatonin and Zolpidem in Tablets Dosage Forms By RP-HPLC Method. International Journal of Biological and Pharmaceutical Research. 2012; 3(4): 640-645.
12. Malesevic M, Zivanovic L, Protic A, Jovic Z. Multiobjective optimization approach in evaluation of chromatographic behaviour of zolpidem tartrate and its degradation products. Chromatographia. 2011; 74:197–208.