Sat, 16 Dec 2017

UV-AUC Method Development and Validation for Estimation of 1h, 1-H-2, 2-Bibenzimidazole Impurity in Telmisartan Bulk and Formulation

Poonam P. Patil*1, Veena S. Kasture2, K. Vanitha Prakash3

1-  Research scholar Jawaharlal Nehru technological university, Hyderabad; Department of pharmaceutical chemistry, SRES’s Sanjivani College of Pharmaceutical Education and Research, Kopargaon, MS, India-423 603.

2-  Department of pharmaceutical chemistry, SRES’s Sanjivani College of Pharmaceutical Education and Research, Kopargaon, MS, India-423 603.

3-  Department of pharmaceutical chemistry, SSJ College Of Pharmacy Vattinagula Pally, Gandipet, Hyderabad, Rangareddy Dist. Telangana, India-500 075.


ABSTRACT

The aim of present work was to develop an accurate, precise, reproducible and economical UV spectrophotometric method for estimation of 1H, 1’-H-2, 2’-Bibenzimidazole Impurity In Telmisartan Bulk and Formulation. This method was based on area under curve of UV spectrum between 235 to 254 nm and validated as per ICH guideline Q2 (R1). The method has followed linearity in the range of 5-30μg/ml. The value of correlation coefficient was 0.998. Satisfactory values of Percent relative standard deviation for the intra-day and inter-day precision indicated that method is precise. Results of the recovery studies (97.63% to 98.66 %) showed accuracy of the method. LOD and LOQ were calculated as 0.3221μg/ml and 0.9761 μg/ml, respectively. The developed method can be used for routine estimation of 1H, 1’-H-2, 2’-Bibenzimidazole Impurity In Telmisartan Bulk and Formulation.

Keywords: Telmisartan, UV spectrophotometry, Area under curve, Validation, Impurity


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