DEVELOPMENT AND VLAIDATION OF SIMPLE UV-SPECTROPHOTOMETRIC METHOD OF QUANTIZATION OF DIAZEPAM IN BULK DRUG AND SOLID DOSAGE FORMULATION USING MIXED SOLVENCY CONCEPT
Objective: Commonly used organic solvents for spectrophotometric analysis of water insoluble drugs are methanol, ethanol, chloroform, benzene, toluene etc. The main drawbacks of organic solvents include high cost, toxicity, and pollution. Organic solvents have numerous adverse effects caused by single exposure like dermatitis, headache, drowsiness, nausea, eye irritation and long term exposure causes serious effects such as neurological disorder, chronic renal failure, and liver damage. They should be replaced by other ecofriendly alternative sources.
Methods: The present study is an attempt to show that solid can also be used to act as solvent precluding the use of organic solvents. A simple, safe and sensitive method of spectrophotometric determination of diazepam obeyed beers law in the concentration range of 5-25 mcg/ml at 306 nm.
Results: The results of analyses have been validated statistically for Linearity, accuracy, precision, LOD and LOQ. The results of validation parameters also indicated that proposed method was found to be accurate, precise, reproducible, sensitive, and suitable for routine quality control analysis for estimation of diazepam in bulk drug and solid dosage formulation.Conclusion: A rapid, simple, and non toxic UV spectrophotometric method has been developed for the determination and quantification of diazepam. The present method also validated as per ICH guidelines for linearity, precision, accuracy.
2. Maheshwari RK. Solubilization of ibuprofen by mixed solvency approach. Indian Pharm 2009;8:81-4.
3. Maheshwari RK. Mixed-solvencyâ€“a novel concept for solubilization of poorly water-soluble drugs. Delving J Tech Eng Sci 2009;1:39-43.
4. Maheshwari RK. Solid as solvent-novel spectophotometric analysis of satranidazole tablets using phenol as solvent. Indian Pharm 2014;12:37-40.
5. Maheshwari RK. Solid as solvent-novel spectophotometric analysis of norfloxacin tablets using phenol as solvent. Int J Curr Pharm Res 2014;6:76-8.
6. Maheshwari RK. Potentiation of solvent character by mixed solvency concept: a novel concept of solubilization. J Pharm Res 2010;3:411-3.
7. Maheshwari RK, Shilpkar R. Formulation development and evaluation of injection of poorly soluble drug using mixed solvency concept. Int J Pharm Biosci 2012;3:179-89.
8. Maheshwari RK, Upadhyay N, Jain J, Patani M, Mathuria KC. New spectrophotometric estimation of naproxen tablet formulation employing mixed solvency concept (at 331 nm). Int J Pharm Technol 2011;3:3618-23.
9. Maheshwari RK, Rajagopalan R. Formulation and evaluation of tinidazole syrup made by mixed-solvency concept. Pharm Lett 2011;3:266-71.
10. Maheshwari RK, Karawande VU. Application of novel concept of mixed solvency in the design and development of floating microspheres of furosemide. Int J Pharm Pharm Sci 2013,15:167-95.
11. Maheshwari RK, Upadhyay N, Jain J, Patani M, Pandey R. New spectrophotometric analysis of gatifloxacin tablets utilizing mixed solvency concept (at 288 nm). Pharm Lett 2012;4:1-4.
12. Prashant B, Rawat S, Mahajan YY, Galgatte UC, Maheshwari RK. Formulation development and evaluation of aqueous injection of poorly soluble drug made by novel application of mixed solvency concept. Int J Drug Delivery 2013;2:152-66.
13. Maheshwari RK, Rajagopalan R. Formulation and evaluation of paracetamol syrup made by mixed-solvency concept. Pharm Lett 2012;4:170-4.
14. Chandna C, Maheshwari RK. Mixed solvency concept in reducing surfactant concentration of self emulsifying drug delivery systems of candesartan cilexetil using D-optimal mixture design. Asian J Pharm 2013;7:83-91.
15. Maheshwari RK, Upadhyay N, Jain J, Patani M, Mathuria KC. New spectrophotometric estimation of naproxen tablet formulation employing mixed solvency concept (at 331 nm). Int J Pharm Technol 2011;3:3618-23.
16. Agrawal A, Maheshwari RK. Formulation development and evaluation of in situ nasal gel of poorly water soluble drug using mixed solvency concept. Asian J Pharm 2011;5:131-40.
17. Bhawsar N, Maheshwari RK, Ansari A, Saktawat Y. New spectrophotometric estimation of gatifloxacin in the tablets using mixed solvency approach. Int J Pharm Sci 2011;2:270-4.
18. Soni LK, Solanki SS, Maheshwari RK. Solubilization of poorly water soluble drug using mixed solvency approach for aqueous injection. Br J Pharm Res 2014;4:549-68.
19. Maheshwari RK, Gupta S, Gharia A, Garg SK, Shilpkar R. Simple eco-friendly spectrophotometric estimation of tinidazole tablets by application of mixed-ssolvency technique. Bull Pharm Res 2011;1:22-5.
20. Maheshwari RK. Solid as solvent-novel spectrophotometric analysis of tinidazole tablets using melted phenol as solvent. Asian J Pharm Res 2015;5:21-4.
21. Maheshwari RK, Putliwala M, Padiyar A. Novel approach for spectrophotometric estimation of naproxen in tablet dosage form using solids (eutectic liquid of phenol and niacinamide) as solubilising agents. Asian J Pharm Res 2015;5:25-8.
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