Analytical Methods in Environmental Chemistry Journal
AMECJ

Analysis and validation of pure and synthetic Nizatidine drug by reversed-phase high-performance liquid chromatography

Document Type : Original Article

Authors

DeviReddy Prashanthi 1
Nanjedevanapura Mahadevegowda Kavana 1
Mathad Shivamurthaiah Chaithanya 1
Siddalingappa Tippanna Bhagawathi 2
Veeresh Prabhakar Veerapur 3

1 Department of Pharmaceutical Quality Assurance, Sree Siddaganga College of Pharmacy, Tumkur-103 572, Karnataka, India

2 Department of Pharmaceutics, Sree Siddaganga College of Pharmacy, Tumkur-103 572, Karnataka, India

3 a Department of Pharmaceutical Quality Assurance, Sree Siddaganga College of Pharmacy, Tumkur-103 572, Karnataka, India

https://doi.org/10.24200/amecj.v8.i02.1019
Abstract
A new reversed-phase high-performance liquid chromatography (RP-HPLC) method was developed and validated for estimating Nizatidine in bulk and from in-house synthesis mixtures. The isocratic method uses the mobile phase of a C8 shim-pack column (250 mm×4.6, 5 μm) with acetonitrile and water (90:10). The wavelength was detected and quantified at 240 nm with a flow rate of 1.1 mL min-1. Peak elution occurred at 2.816 minutes, with 3373 USP theoretical plates and a tailing factor 1.202. The approach was verified regarding system suitability, linearity, specificity, precision, accuracy, robustness, limit of detection (LOD), and limit of quantification (LOQ). The LOD for nizatidine was 0.011 μg mL-1, whereas the LOQ was 0.049 μg mL-1. The linearity range, the percentage RSD, and the correlation coefficient were obtained at 2 -14 μg mL-1, 0.61, and 0.9993, respectively. The proposed method yielded 99.3±0.49 %, 99.1±0.32 %, and 101.2±0.06 % recovery rates for Nizatidine at 80 %, 100 % and 120 % spiking levels. The percentage assay was calculated, and it was found to be 101.9. The proposed approach was verified according to the ICH Q2 (R1) criteria. The approach was accurate, specific, precise, robust, and rugged for estimating Nizatidine in the developed synthetic mixture.

Graphical Abstract

Analysis and validation of pure and synthetic Nizatidine drug by reversed-phase high-performance liquid chromatography

Keywords

Nizatidine
High-performance liquid chromatography
Analytical Validation
ICH Q2 (R1)
Environment
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Analytical Methods in Environmental Chemistry Journal
Volume 8, Issue 2
AMEC Publisher
Spring 2025
Pages 78-92