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K. Faiza Firdos
L. Siva Sanker Reddy
R. Nageswara Rao
S. Muneer
N. Madana Gopal
N. Yella Subbaiah
Shaik Ruksar
K. Maheshwari
C. Madhsudhana Chetty


Secnidazole, Methanol, OPA, HPLC, ICH Guidelines, Secnil


The project was aimed at developing an analytical method to quantify Secnidazole drug either alone or in tablet formulation, including stability studies with the aid of RP-HPLC technique. An analytical method was finalised and inspected consistency of the method by performing the different validation parameters like system suitability, specificity, linearity, accuracy, precision, LOD, LOQ, Robustness and assay. The degradation studies were performed under different physical and chemical conditions by following the ICH guidelines. The column used was Inertsil ODS Column C18 (4.6×250mm)5µm of Shimadzu.


The HPLC was Shimadzu make with UV PDA detector and model 20AD. In the stream lining the analytical method, we have settled on to use the mobile phase with the combination of Methanol: 0.1% OPA (90:10 v/v). The drug was detected at 314 nm on UV-Visible spectrophotometer. The retention time was at 2.953 min with the run time of 10 min. The linearity range of Secnidazole was from 2 µg/ml to 10µg/ml and the Regression coefficient calculated to be (R2) 0.999. The corresponding recognition limits (LOD and LOQ) of the Secnidazole was 0.3µg/ml and 0.9µg/ml respectively. Precision studies were carried out and the RSD values were found to be less than two. The degradation studies were successfully conducted. The significant advantages were reduction of retention time at 1ml/min and the mobile phase used was quite cheaper than the reported methods. The other part was that, the usability of the method to quantify even though the drug was degraded nearly to 10 % in presence of the unknown degradants. The method is also sensitive, reproducible, quick and economical.

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2. Nasiruddin alumad farooqui, A.Anton smith, H.K.Sharma all et al., Analytical Method Development and Validation of Secnidazole Tablets by RP-HPLC, J. Pharm. Sci. & Res. Vol.2 (7), 2010, 412-416.
3. Tanzina Sharmin et., al Analytical method development and validation of secnidazole in the tablet dosage form by RP-HPLC, International current pharmaceutical journal, 2016, March 2016, 5(4): 41-44.
4. Ali Gamal Ahmed Al-Kaf, EL-Rashed. Ahmed Gad kariem, Ali Abdo Saif Ahmed Algaradi1 and Talal Alssmani, Development and Validation of an RP-HPLC Method for Estimation of Secnidazole and Its Degradation Products in Tablets, Glob J Pharmaceu Sci 2016, 1(1), 1-9.
5. Sunitha Rani Ajmera. Development and Validation of new RP-HPLC method for the estimation of Secnidazole in pure and pharmaceutical dosage forms. Asian J. Research Chem. 2018; 11(1):134-138. doi: 10.5958/0974-4150.2018.00028.7
6. Rajan V. Rele all et al., Development of analytical method by RP- HPLC technique for determination of secnidazole in API and pharmaceutical dosage form, journal of pharmacy and Technolog,2019,12(10), 4799-4802.
7. Neeharika Yamsami, Upender Rao Eslawath, Rajashekar Valdakonda Method development and validation of secnidazole in solid dosageform by RP- HPLC, ISOR journal of pharmacy and biological science, 2020, Volume 15, Issue 1 Ser. III (Jan –Feb 2020), PP 38-45.
8. Akash Shelke, Someshwar Mankar, Mahesh Kolhe. Development and Validation of RP-HPLC Method for estimation of Secnidazole in API and Pharmaceutical Dosage Form. Research Journal of Science and Technology. 2021; 13(2):100-4. doi: 10.52711/2349-2988.2021.00015.
9. Guideline ICH. Validation of Analytical Procedures: text and Methodology. Q2 (R1). 2005 Nov;(20):05.
10. Guideline ICH. Stability testing of New Drug Substances and Products: Q1A(R2).2003 Feb;(06).

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