Saturday , 24 October 2020

RP-HPLC Method Development and Validation for Simultaneous Estimation of Tiotropium and Salmeterol in Bulk and Pharmaceutical Dosage Forms

MS.CH.Anusha1, Dr.D.Naresh2, Dr. GampaVijayKumar3*
1KGR Institute of Technology and Management, Rampally, Kesara, Rangareddy, Telangana, India.
2KGR Institute of Technology and Management, Rampally, Kesara, Rangareddy, Telangana, India.
3Professor and Head, Dept. of Pharmacy, KGR Institute of Technology and Management, Rampally, Kesara, Rangareddy, Telangana, India.

A  B  S  T  R A C T
High-performance liquid chromatography is at present one of the most sophisticated tool of the analysis. The estimation of Tiotropium and Salmeterol was done by RP-HPLC. The Phosphate buffer was pH3.0 and the mobile phase was optimized with consists of Methanol: Phosphate buffer mixed in the ratio of 70:30 % v/ v. Inertsil C18 column C18 (4.6 x 150mm, 5mm) or equivalent chemically bonded to porous silica particles was used as stationary phase. The detection was carried out using UV detector at 253 nm. The solutions were chromatographed at a constant flow rate of 0.8 ml/min. the linearity range of Tiotropium and Salmeterol were found to be from 100-500 mg/ml of Tiotropium and 1-5mg/ml of Salmeterol. Linear regression coefficient was not more than 0.999.The values of % RSD are less than 2% indicating accuracy and precision of the method. The percentage recovery varies from 98-102% of Tiotropium and Salmeterol. LOD and LOQ were found to be within limit. The results obtained on the validation parameters met ICH and USP requirements .it inferred the method found to be simple, accurate, precise and linear. The method was found to be having suitable application in routine laboratory analysis with high degree of accuracy and precision.
Keywords: Methanol: Phosphate buffer, Inertsil C18 column, Tiotropium and Salmeterol, RP-HPLC.

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