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DEVELOPMENT AND VALIDATION OF SPECTROSCOPY METHOD FOR SIMVASTATIN IN DIFFERENT DISSOLUTION MEDIA

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Abstract (2. Language): 
The aim of present work is to develop and validate simple, sensitive and specific spectrophotometric method for the determination of Simvastatin, a hypolipidemic drug in pure form and in pharmaceutical formulations. UV spectrophotometric method, which is based on measurement of absorption at maximum wavelength in solvent system employed for the determination of simvastatin was methanol with 0.05% acetic acid, water with 0.03% w/v of SLS, 1.2 pH with 0.03% w/v of SLS, phosphate buffer pH 6.8 and 7.4 pH with 0.03% w/v of SLS, was found to be at 238 nm. The developed method was validated with respect to linearity, accuracy (recovery), precision and specificity. The optimum conditions for analysis of the drug were established. The drug obeyed the Beer's law and showed good correlation. Beer's law was obeyed in concentration range 0-16 u.g/ml. The results of analysis were validated by recovery studies. The method was found to be simple, accurate, precise, economical and robust. This method was extended to formulation and there was no interference from excipients and diluents. This method has been statistically validated and is found to be precise and accurate. Results obtained that are further used for the formulation development.
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REFERENCES

References: 

1. Merck index, Maryadele J.O.Neil Edu.In: 13th ed. Published by Merck Research lab., NJ, USA. 2001: 868.
2. Ochiai H, Uchiyama N, Imagaki K, Hata S and Kamei T. Determination of simvastatin and its active metabolites in human plasma by column-switching high performance liquid chromatography with fluorescence detection after derivatization with 1-bromoacetylpyrene. J Chromatogr B Biomed Sci. 1997; 694(1): 211-217.
3. Merck index, Maryadele J.O.Neil Edu.In: 13th ed. Published by Merck Research lab., NJ, USA.2001: 148.
4. Darkes MJ, Poole RM and Goa KL. Ezetimibe. Am J Cardio Vasc Drugs.2003;
3(1): 67-76.
5. Grundy SM and Vega GL, "Hypertriglyceridemia: causes and relation to coronary heart disease". Semin. Thromb. Hemost. 1988;14: 249¬264.
6. Morris MJ, Gilbert JD, Hsieh JY, Matuszewski BK, Ramjit HG and Bayne WF. Determination of the HMG- CoA reductase inhibitors simvastatin, lovastatin and pravastatin in plasma by gas chromatography/chemical ionization
Available Online At www.ijprbs.com
Research Article
Bhavisha Rabadiya, IJPRBS, 2013; Volume 2(3): 25-41
ISSN: 2277-8713
IJPRBS
mass spectrometry. Biol Mass Spectrom.
1993; 22(1):1-8.
7. Tan L, Yang LL, Zhang X, Yuan YS and Ling SS. Determination of simvastatin in human plasma by high performance liquid chromatography.2000;18(3) : 232¬234.
8. Curlucci G, Mazzeo P, Biordi L and Bologna M. Simultaneous determination of simvastatin and its hydroxy acid form in human plasma by high performance liquid chromatography with UV detection. J Pharm Biomed Anal. 1992;
10(9): 693-7.
9. Wang L and Asgharnejad M. Secondderivative UV spectrometric determination of simvastatin in TABLEt dosage form. J Pharm Biomed Anal.
2000; 21(6): 1243-1248.
10. State Pharmacopoeia, Vol. XXIV, NF-25, United States Pharmacopoeial Convention, Rockville, MD, 2007: 3179.
11. Boppana R, Kulkarni RV, Mutalik SS, Setty CM, Sa B, "Interpenetrating network hydrogel beads of carboxymethyl cellulose and egg albumin for controlled release of lipid lowering
drug". J Microencapsul. 2010; 27(4): 337¬344.
12. Validation of analytical procedures / methodology, ICH harmonized triplicate guideline. 1996: 1¬8.

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