DEVELOPMENT AND VALIDATION OF STABILITY INDICATING HPLC AND UV METHOD FOR PROTEASE INHIBITOR: A REVIEW

被引:0
作者
Patil, Akshay B. [1 ]
Gurumukhi, Vishal C. [1 ]
Chalikwar, Shailesh S. [1 ]
Chaudhari, Dhanshri A. [1 ]
机构
[1] RC Patel Inst Pharmaceut Educ & Res, Dept Pharmaceut Qual Assurance, Shirpur, India
来源
INDO AMERICAN JOURNAL OF PHARMACEUTICAL SCIENCES | 2019年 / 6卷 / 04期
关键词
RP-HPLC; UV-spectrophotometry; Validation; Stability indicating; PERFORMANCE LIQUID-CHROMATOGRAPHY; HUMAN PLASMA; QUANTITATIVE-DETERMINATION; ANTIRETROVIRAL AGENTS; NELFINAVIR MESYLATE; ATAZANAVIR; RITONAVIR; INDINAVIR; SAQUINAVIR; DRUG;
D O I
10.5281/zenodo.2652047
中图分类号
R914 [药物化学];
学科分类号
100701 ;
摘要
A technique for the analysis of various duds using RP-HPLC and UV is an essential tool in chromatography. The HPLC method is able to separate, detect and selectively quantify the various drugs. After the method development using HPLC validation is done for the performance and reproducibility and repeatability and accuracy. Also, it will help to find out the limitations of the method and influence of factors to quantify the drug. Further, according to ICH guidelines, the established method processed with stability indicating evaluation to find out the robustness of the method. It includes forced degradation with acidic, basic, neutral condition, oxidation, photolytic degradation also done. In this review, we presented a protease inhibitor class drug and its quantification using HPLC and UV.
引用
收藏
页码:8381 / 8400
页数:20
相关论文
共 46 条
  • [21] Simple high-performance liquid chromatographic determination of the protease inhibitor indinavir in human plasma
    Jayewardene, AL
    Zhu, F
    Aweeka, FT
    Gambertoglio, JG
    [J]. JOURNAL OF CHROMATOGRAPHY B, 1998, 707 (1-2): : 203 - 211
  • [22] Determination of nelfinavir mesylate as bulk drug and in pharmaceutical dosage form by stability indicating HPLC
    Jing, Qiufang
    Shen, Yongjia
    Tang, Yanhui
    Ren, Fuzheng
    Yu, Xinhong
    Hou, Zhian
    [J]. JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS, 2006, 41 (03) : 1065 - 1069
  • [23] Khanage SG, 2010, Int J Pharm Health Sci., V1, P149
  • [24] Konidala S. K., 2012, INT J PHARM PHARM SC, V4, P614
  • [25] Konidala SK, 2012, Pharm Chem, V4, P1305
  • [26] Simple determination of the HIV protease inhibitor atazanavir in human plasma by high-performance liquid chromatography with UV detection
    Loregian, Arianna
    Pagni, Silvana
    Ballarin, Elisa
    Sinigalia, Elisa
    Parisi, Saverio Giuseppe
    Palu, Giorgio
    [J]. JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS, 2006, 42 (04) : 500 - 505
  • [27] Nanda R.K., 2011, PHARM CHEM, V3, P84
  • [28] Nanotechnology and the Treatment of HIV Infection
    Parboosing, Raveen
    Maguire, Glenn E. M.
    Govender, Patrick
    Kruger, Hendrik G.
    [J]. VIRUSES-BASEL, 2012, 4 (04): : 488 - 520
  • [29] RP-HPLC method for the estimation of dutasteride in tablet dosage form
    Patel, Dipti B.
    Patel, N. J.
    Patel, S. K.
    Prajapati, A. M.
    Patel, S. A.
    [J]. INDIAN JOURNAL OF PHARMACEUTICAL SCIENCES, 2010, 72 (01) : 113 - 116
  • [30] Development and validation of a reversed-phase liquid chromatographic method with fluorescence detection for the study of Saquinavir pharmacokinetics in rat plasma
    Pathak, Shriram M.
    Kumar, A. Ranjith
    Subramanian, G.
    Udupa, N.
    [J]. ANALYTICA CHIMICA ACTA, 2007, 594 (02) : 248 - 256