Author(s):
Ramu Samineni, Jithendra Chimakurthy, Sathish Kumar Konidala, Venkateswarao Yamarthy
Email(s):
samineni.ramu@gmail.com
DOI:
10.52711/0974-360X.2022.00499
Address:
Ramu Samineni*, Jithendra Chimakurthy, Sathish Kumar Konidala, Venkateswarao Yamarthy
Faculty of Pharmacy, Department of Pharmaceutical Sciences, Vignan’s Foundation for Science, Technology and Research, Vadlamudi, Guntur, Andhra Pradesh-522213.
*Corresponding Author
Published In:
Volume - 15,
Issue - 7,
Year - 2022
ABSTRACT:
The objective of the present study is to develop simple, accurate, sensitive and economic method for effective quantitative determination of Balofloxacin in active pharmaceutical ingredient. as well as in Pharmaceutical dosage forms by using HPLC. The newly developed method is validated in accordance with the analytical parameters for quantitative estimation of Balofloxacin in pharmaceutical dosage forms as per ICH guidelines. The method was validated for parameters like accuracy, linearity, precision, specificity, ruggedness, robustness, and system suitability. The detection was carried out using UV detector at 249 nm. The solutions were injected at a constant flow rate of 1 ml/min. the linearity range of Balofloxacin was found to be 10-60 ?g/ml. The values of % RSD are less than 2% indicating accuracy and precision of the method. The percentage recovery varies from 98-102% of Balofloxacin. LOD were found to be 0.210 µg/ml and LOQ found to be 0.637µg/ml for Balofloxacin. The results obtained on the validation parameters met ICH guidelines; it inferred the method found to be simple, accurate, precise and linear. The method was found to be having suitable application in routine laboratory analysis with high degree of accuracy and precision.
Cite this article:
Ramu Samineni, Jithendra Chimakurthy, Sathish Kumar Konidala, Venkateswarao Yamarthy. Development and Validation of Analytical Method for Estimation of Balofloxacin in Bulk and Pharmaceutical Dosage Form by RP-HPLC. Research Journal of Pharmacy and Technology. 2022; 15(7):2992-6. doi: 10.52711/0974-360X.2022.00499
Cite(Electronic):
Ramu Samineni, Jithendra Chimakurthy, Sathish Kumar Konidala, Venkateswarao Yamarthy. Development and Validation of Analytical Method for Estimation of Balofloxacin in Bulk and Pharmaceutical Dosage Form by RP-HPLC. Research Journal of Pharmacy and Technology. 2022; 15(7):2992-6. doi: 10.52711/0974-360X.2022.00499 Available on: https://rjptonline.org/AbstractView.aspx?PID=2022-15-7-21
REFERENCES:
1. Skoog et al., Principles of Instrumental Analysis. Barkhanath publishers, 8th edition, Pg. no. 973-995.
2. J Bagyalakshmi. S Vijayaraj. Sindhu. TK Ravi. Method Development and Validation of Erythrosine (E127) Using RP-HPLC Coupled with PDA Detector. Asian J. Research Chem. 2008; 1(2): 95-96.
3. Akhilesh Gupta. Swati rawat Rawat. Mayuri Gandhi. Jaydeep Singh Yadav. Method Development and Acid Degradation Study of Doxofylline by RP-HPLC and LC-MS/MS. Asian J. Pharm. Ana. 2011; 1(1): 10-13.
4. L. Satyanarayana. S.V. Naidu. M. Narasimha Rao. C. Ayyanna. Alok Kumar. The Estimation of Raltigravir in Tablet dosage form by RP-HPLC. Asian J. Pharm. Ana. 2011; 1(3): 56-58.
5. Janaki pathi.P. Appala Raju.N. Analytical Development and Validation of RP-HPLC method for the estimation of Epalrestat in tablet dosage form, Asian J. Pharm. Ana. 2012; 2(2): 49-51.
6. Md. Ahsanul Haque. Mohammad Shahriar. Most. Nazma Parvin. S. M. Ashraful Islam. Validated RP-HPLC Method for Estimation of Ranitidine Hydrochloride, Domperidone and Naproxen in Solid Dosage Form. Asian J. Pharm. Ana. 2011;1(3): 59-63.
7. Mahmoud M Sebaiy. Abdullah A. El-Shanawany. Sobhy M. El-Adl. Lobna M. Abdel-Aziz. Hisham A. Hashem. Rapid RP-HPLC Method for Simultaneous Estimation of Norfloxacin and Tinidazole in Tablet Dosage Form. Asian J. Pharm. Ana. 2011;1(4): 79-84.
8. J. Nagamallika. Aruna Mahesh. Development and Validation of Spectrophotometric Method for the Estimation of Aripiprazole in Tablet Dosage Form. Asian J. Pharm. Ana. 2011;1(3): 46-49.
9. Sharmin Reza Chowdhury. Mahfuza Maleque. Mahbubul Hoque Shihan. Development and Validation of a Simple RP-HPLC Method for Determination of Caffeine in Pharmaceutical Dosage Forms. Asian J. Pharm. Ana. 2012; 2(1): 01-04.
10. C R Nicolay. S Purkayastha. A Greenhalgh. J Benn, S Chaturvedi. N Phillips. A Darzi. Systematic review of the application of quality improvement methodologies from the manufacturing Industry to Surgical Healthcare. 2012; 99(3): 324-35. doi.org/10.1002/bjs.7803
11. M Balaji. I Srikanth. S Reddy. G Krishna. S Ramu. V Kumar. Development and validation of RP-HPLC method for quantitative estimation of tenofovir disoproxil fumarate in bulk and pharmaceutical dosage form. J Pharm Res. 2012; 5(1): 4692-4694.
12. Ramu Samineni. K Sumalatha. G Dharani. J Rachana. P Anitha. K Manasa. Formulation and Evaluation of Oral Disintegrating Tablets of Montelukast Sodium and Desloratidine. Res. J. Pharma. Dosage Forms and Tech.2019; 11(3):152-158. doi.org/10.5958/0975-4377.2019.00026.0
13. Ramu Samineni. Co-Crystals: A Review of Recent Trends in Co Crystallization of BCS Class II Drugs. Research J. Pharm. and Tech. 2019; 12(7):3117-3124. doi.org/ 10.5958/0974-360X.2019.00527.4
14. Gaurav Tiwari. Ruchi Tiwari. Brijendra Srivastava. Awani K Rai. Kamla Pathak. Simultaneous Estimation of Metronidazole and Amoxicillin in Synthetic Mixture by Ultraviolet Spectroscopy. Asian J. Research Chem. 2008; 1(2): 91-94.
15. Jajow Swapna. Chandaka Madhu. Mallepelli Srivani. M. Sumalatha. Y. Nehalatha. Y. Anusha. Analytical Method Development and Method Validation for the Simultaneous Estimation of Metformin hydrochloride and Pioglitazone hydrochloride in Tablet Dosage Form by RP-HPLC. Asian J. Pharm. Ana. 2012; 2(3): 85-89.