Development and Validation of HPLC Method for Diphenhydramine Hydrochloride

Abstract

Aim: The aim of present method development for Diphenhydramine HCl performed on HPLC is to obtain specific, more accurate and precise results as compare to spectrophotometric method.
 Methods: HPLC analysis was performed according to USP method with wavelength detection at 220nm and 1.0ml/min flow rate. Wufeng thermo HPLC system UV -100detector was used having column C18(4.6mm*250mm) 5. Methanol and water (4:1) mixture was used as mobile phase and pH was adjusted at 7.4 with the help of triethanolamine. Validation parameters like linearity, accuracy, precision, solution stability, robustness, LOD, LOQ and system suitability were successfully evaluated.
 Results: The regression co-efficient for calibration curve was 0.991 and % recovery was in range (80-110%), whereas no robustness was observed in this reported method.
 Conclusion: In summary, the expected linearity, accuracy and % recovery indicating that HPLC is more precise method than spectrophotometry and suggested that present method qualifies the validation criteria.

Continuous Flow Injection Analysis Method for the Determination of a Drug Diphenhydramine Hydrochloride by Using Phosphomolybdic Acid

“…It's one of the antihistamines and falls into the category of the first generation of antihistamines 2,3 .It's used alone Published Online First: January, 2024 https://doi.org /10.21123/bsj.2024.8926 P-ISSN: 2078-8665 -E-ISSN: 2411 Baghdad Science Journal or in combination with other medicine 4 .Diphenhydramine hydrochloride is prescribed to relieve allergy symptoms , to treat motion sickness, as an anti-emetic and anti-couch ,in cases of bee stings and skin itching and to treat some cases of runny nose and eyes 5 . There are several methods for estimating diphenhydramine hydrochloride in literature; we mention some of them: spectrophotometric methods 6,7 , chromatographic methods [8][9][10][11] , flow injection 12,13 and potentiometric methods 14 . In this study, a new method was introduced within the continuous flow injection analysis technique [15][16][17][18] ,using homemade cells [19][20][21][22] , which depends on fluorescence or turbidity [23][24][25][26] as it is an easy, simple, sensitive, safe and inexpensive method to control the quality of DPH-containing drug tablets using homemade Ayah 6S×1-ST-2D solar cell CFI analyzer 27 , which has been successfully used in the determination of some drugs and some elements 28 .…”