Development and Validation of RP-HPLC Method for the Simultaneous Estimation of Ambroxol Hydrochloride and Loratadine in Tablet Dosage Form

Keeran, G (2021) Development and Validation of RP-HPLC Method for the Simultaneous Estimation of Ambroxol Hydrochloride and Loratadine in Tablet Dosage Form. Masters thesis, Padmavathi College of Pharmacy, Dharmapuri.

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Abstract

High performance liquid chromatography is at present one of the most sophisticated tool of the analysis. The estimation of Ambroxol Hcl and Loratadine was done by RP-HPLC. The Phosphate buffer was pH 5.0 and the mobile phase was optimized with consists of Acetonitrile: Phosphate buffer mixed in the ratio of 70:30 % v/ v. A C18 column C18 (4.6 x 250mm, 5µm, Make: Waters) or equivalent chemically bonded to porous silica particles was used as stationary phase. The detection was carried out using UV detector at 245 nm. The solutions were chromatographed at a constant flow rate of 1.0 ml/min. the linearity range of Ambroxol Hcl and Loratadine were found to be from 96-192 µg/ml. of Ambroxol Hcl and 8-16g/ml of Loratadine. 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 97-102% of Ambroxol Hcl and Loratadine. 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.

Item Type: Thesis (Masters)
Additional Information: Reg.No.261931002
Uncontrolled Keywords: Development, Validation, RP-HPLC Method, Simultaneous Estimation, Ambroxol Hydrochloride, Loratadine, Tablet Dosage Form.
Subjects: PHARMACY > Pharmaceutical Analysis
Depositing User: Subramani R
Date Deposited: 24 May 2023 02:48
Last Modified: 24 May 2023 02:48
URI: http://repository-tnmgrmu.ac.in/id/eprint/21270

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