Tuesday , 5 March 2024

Analytical Method Development and Validation for the Estimation of Betahistine HCL by RP-HPLC Method in Bulk and Pharmaceutical Dosage Form

B. Karuna Devi1, G. Sravan Reddy2, SK. Madeesh*3, V. Raja Kumar4, Ramanjineyulu Gunji5
1Malla Reddy College of Pharmacy, Maisammaguda, Dhulapally, Kompally, Medchal, Hyderabad-500014
2CEO, KP Technologies, Kothapet, Hyderabad- 500035
3Manager, Analytical Research and Development, KP Labs, Kothapet, Hyderabad- 500035
4St. John S College of Pharmacy, Yellapur, Hasanparthy, Warangal
3Research Associate, Analytical Research and Development, KP Labs, Kothapet, Hyderabad- 500035

The chromatographic conditions were successfully developed for the separation of Betahistine HCL by using Agilent C18  Column (150mm x 4.6mm)5µm, flow rate was 1ml/min, mobile phase ratio was Methanol: Phosphate buffer (75:25 v/v), detection wavelength was 270 nm. The Spectroscopic method was done in solvent using mobile phase and the instrument lab India 3000+ with UV win software. The instrument used was WATERS HPLC Auto Sampler, Separation module 2695, photo diode array detector, Empower-software version 2. The retention time was found to be 2.145 min. The % purity of Betahistine HCL was found to be 98.56%. The system suitability parameters for Betahistine HCL such as theoretical plates and tailing factor were found to be 4343, 1.6. The analytical method was validated according to ICH guidelines (ICH, Q2 (R1)). The linearity study of Betahistine HCL was found in concentration range of 20µg-100µg and correlation coefficient (r2) was found to be 0.999 respectively, % recovery was found to be 98.96% respectively. %RSD for repeatability and precision was found to be <2.LOD value was 0.439 and LOQ value was found to be 1.466 respectively for Betahistine HCL.
Keywords: Betahistine HCL, HPLC.

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