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THE PHARMA REVIEW (SEPTEMBER - OCTOBER 2011)

Spectrophotometric and Chromatographic Method for Estimation of Nitroxazepine HCL in Bulk and Dosage form

R.B. Kakde*and S.G. Rangari

Abstract
This paper describes two simple, specific, accurate and precise ultra-violet spectrophotometry (UV) and high-performance thin layer chromatographic (HPTLC) methods for estimation of Nitroxazepine Hydrochloride in bulk drug and tablet dosage form. In spectrophotometry, the standard stock solution was prepared in water. The λmax of Nitroxazepine HCl was found to be 268 nm. The absorptivity value of Nitroxazepine HCl was found to be 484.36 2.51. Graph was linear over the range of 2-20 g/ml. The results of estimation of marketed tablet formulation was found to be 99.83 1.004. In HPTLC, mobile phase is methanol and ammonium acetate in the proportion of 8.8:1.2 v/v. Merck TLC plate precoated 60 F254 silica gel on aluminum sheet is used as stationary phase. Detection was carried out densitometrically using UV detector at 283 nm. The retention factor (Rf ) of Nitroxazepine HCl was 0.47 0.02.
The linearity of response was found to be linear in the range of 100-700 ng/spot with correlation coefficient value are 0.994 and 0.997 for height and area. The developed spectrophotometry and HPTLC methods were validated using various validation parameters such as accuracy, precision, specificity, limit of detection, limit of quantitation and ruggedness, which make method as choice for routine quality control analysis for estimation of Nitroxazepine HCl in tablet formulation.

 

 

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