Development and Validation of a Reverse Phase-High Performance Liquid Chromatography Method for the Assay of Benazepril Hydrochloride using a Quality-By-Design Approach

被引:0
作者
Kiran, S. [1 ]
Pasha, T. Yunus [1 ]
Asif, Mohammad [2 ]
Kamal, Mehnaz [3 ]
Jawaid, Talha [4 ]
Alossaimi, Manal A. [3 ]
Ramesh, B. [1 ]
Majumder, Manish [1 ]
机构
[1] Adichunchanagiri Univ, Sri Adichunchanagiri Coll Pharm, Dept Pharmaceut Anal, Bg Nagara 571448, Karnataka, India
[2] Glocal Univ, Glocal Sch Pharm, Saharanpur 247121, Uttar Pradesh, India
[3] Prince Sattam Bin Abdulaziz Univ, Dept Pharmaceut Chem, Coll Pharm, Al Kharj 11942, Saudi Arabia
[4] Al Imm Mohammad Ibn Saud Islam Univ IMSIU, Dept Pharmacol, Coll Med, Riyadh 13317, Saudi Arabia
来源
LATIN AMERICAN JOURNAL OF PHARMACY | 2022年 / 41卷 / 05期
关键词
benazepril HCl; method development; retention time; RP-HPLC; tailing factor; validation; HYDROCHLOROTHIAZIDE;
D O I
暂无
中图分类号
R9 [药学];
学科分类号
1007 ;
摘要
The current research involves using quality by design approaches to develop and validate a stability-indicating reverse phase high-performance liquid chromatography (RP-HPLC) method for chosen Benazepril hydrochloride (HCl). The RP-HPLC method's quality target method profile and critical analytical attributes (CAAs) were determined. For benazepril, method optimization was carried out utilizing a central composite design that took into account buffer concentration and pH, flow rate, and percent organic modifier. From risk assessment and factor screening tests, flow rate, water concentration, and column temperature were identified as key method parameters (CMPs) and investigated for their impact on retention time (RT) and tailing factor (TF) for benazepril HCl as CAAs. Benazepril HCI was separated using a Waters Atlantis T3 column (250 x4.6 mm x 5 m) with mobile phase in the ratio of 59 mM potassium phosphate buffer (pH 5.4):methanol (69:31), at a flow rate of 0.59 mL/min., with UV detection at 225 nm and using acetonitrile: water (60:40) at a flow rate of 1.1 ml/min, with UV detection at 237 nm, respectively. The RI of Benazepril HCl was discovered to be 2.25 min. According to ICH guidelines, the developedmethod was validated. The method's linearity, specificity, accuracy, and precision were all validated, and the results were satisfactory. The method is cost-effective, precise, accurate, and linear at concentrations ranging from 50 to 350 ng/mL for benazepril HCl.
引用
收藏
页码:931 / 943
页数:13
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