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AN UPDATED & MODERN CONCEPT OF VALIDATION

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ABOUT AUTHORS:
Somsubhra Ghosh1*, B. V. V. Ravikumar2, B. Mahanti1
1Bharat Technology, Banitabla, Uluberia, West Bengal
2Roland Institute of Pharmaceutical Sciences, Berhampur, Odisha
som_subhra_ghosh@yahoo.co.in

ABSTRACT
Validation is a very important tool in GMP. Main aim & objective of GMP to all Pharmaceutical agencies are to provide a good & reasonable quality of Pharmaceutical products to people. To get that desired quality Validation is great support to all Pharmaceutical & other industry people. Validation is also a very important tool to save money, time, labourer, waste material etc. There are different types of Validation used all over the world by which we can achieve our goal very easily. In this review it is briefly described scope, importance, objectives & types of Validation as per international norms. Now days it became so important that without validation any process, method or instrument are not accepted globally.

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ABSORBANCE CORRECTION METHOD FOR SIMULTANEOUS ESTIMATION OF AMLODIPINE BESYLATE AND SIMVASTATIN IN SYNTHETIC MIXTURE

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ABOUT AUTHROS:
Vandana M Patel*, Hasumati A Raj, Vineet C Jain
*Shree Dhanvantary College of Pharmacy,
Kim, Surat, Gujarat, India.
vandanapatel@gmail.com

ABSTRACT
A simple, accurate and precise spectroscopic method was developed for simultaneous estimation of Amlodipine besylate and Simvastatin in synthetic mixture using Absorbance correction  method. At  360.80  nm (λmax of Amlodipine besylate) Simvastatin has zero absorbance so Amlodipine besylate is directly estimate at 360.80 nm. At 237.60 nm (λmax of Simvastatin) both drugs have some absorbance so Simvastatin is estimate at 237.60 nm using absorbance correction method. The method was found to be linear (r2>0.999) in the range of 5-10 μg/ml for Amlodipine besylate at 360.80 nm. The linear correlation was obtained (r2>0.999) in the range of 5-10 μg/ml for Simvastatin at 237.60 nm. The limit of determination was 0.17 μg/ml and 0.10μg/ml for Amlodipine besylate and Simvastatin, respectively. The limit of quantification was 0. 54μg/ml and 0. 32μg/ml for Amlodipine besylate  and Simvastatin, respectively. The accuracy of these method were evaluated by recovery studies and good recovery result were obtained greater than 99%. The method was successfully applied for simultaneous determination of Amlodipine besylate and Simvastatin in binary mixture.

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