Method development, validation and comparative study of generic Vs. branded generic formulations of amoxicillin trihydrate in capsule dosage form
The present work relates to development and validation of simple, precise and sensitive UV spectrometric and high-performance thin layer chromatographic (HPTLC) method for the analysis of Amoxicillin Trihydrate in Capsule dosage form. Method were developed and applied for comparative study of generic vs branded generic formulations of Amoxicillin Trihydrate. Amoxicillin Trihydrate in methanol shows maximum absorbance at 229 nm and the data of linear regression analysis indicated a good linear relationship over the concentration range of 5-30 µg/ml with a correlation coefficient (R2) 0.998 by UV- Spectroscopy and the concentration range of 2000-12000 ng/band with a correlation coefficient (R2) 0.997 by HPTLC. The main objective was to compare and evaluate the price and quality of branded generic and generic formulations of Amoxicillin Trihydrate 250 mg Capsule. The evaluation parameters like content of active ingredients, content uniformity test, mass variation, disintegration test, and in vitro release studies were performed as described in Indian Pharmacopeia 2010.
Keywords: Branded Generic, Generic, Quantitative and Qualitative Determination, Ultraviolet Spectroscopy, HPTLC, Comparative Studies.
4. Nabeel SO, Rana Sámi AL-Saffar, Spectrophotometric Determination of Amoxicillin in Pharmaceutical Preparations, International Journal of Enhanced Research in Science Technology & Engineering, 2015, 4(6), 167-173.
5. Rajan V., Simultaneous Spectrophotometric Estimationof Amoxicillin and Carbocisteine By Secondorder Derivative Spectroscopy Method in Combined Dosage Form, International journal chemical sciences, 2014, 12(4), 1587-1595.
6. Dr. Wadher S, Kalyankar T, Shivpuje S, Lamture S And Khandre S, Development and Validation of Stability Indicating UV Spectrophotometric Method for Simultaneous Estimation of Amoxicillin Trihydrate And Metronidazole In Bulk And In-House Tablet, World Journal Of Pharmaceutical And Medical Research, 2017,3(8), 312-318.
7. Wadher S J., Patwekar S L., Shivpuje S S., Khandre S S., Lamture S S., Manisha P. P, Stability Indicating Assay Methods for Simultaneous Estimation of Amoxicillin Trihydrate And Cloxacillin Sodium in Combined Capsule Dosage Form by UV -Spectrophotometric Method, European Journal of Biomedical and Pharmaceutical Sciences, 2017, 4(10), 858-864.
8. Pawar* V. K., Garg G., Awasthi R., Nitin K and Kulkarni G. T., Development and Validation of a Simple UV Method for In Vitro Determination of Amoxicillin Trihydrate in New Gastroretentive Dosage Form, International Journal of Pure & Applied Chemistry ,2010, 5(4), 329-333.
9. Prakash K., Narayana R P., Shanta K K. And Lakshmi N M., Spectrophotometric Estimation of Amoxicillin Trihydrate In Bulk and Pharmaceutical Dosage Form, European Journal of Chemistry, 2008, 5(S2), 1114-1116.
10. Nalini K S, Madhusmita S, Veerachamy A, Srividya B and Chinmaya K S, Validation of Assay Indicating Method Development of Amoxicillin in Bulk and One of Its Marketed Dosage Form by RP-HPLC, Annals of Chromatography and Separation Techniques, 2016, 2(1), 1014.
11. Mei-chich hsu and Pei-wen hsu, High-Performance Liquid Chromatographic Method for Potency Determination of Amoxicillin in Commercial Preparations and for Stability Studies, Antimicrobial agents and chemotherapy, June 1992, 36(6) 1276-1279.
12. Valentina P1, Dobrina D T, Danka P O, Milen D, Stojan P, Peter A, Validation of TLC – Densitometric Method for Quality Control of Amoxicillin in Dosage Drug Products, World Journal of Pharmacy and Pharmaceutical Sciences, 2014, 3(5), 995-1008.
13. Kanchan C and Vishnu C, Development and Validation of Stability indicating HPTLC Method for Estimation of Carbocisteine and Amoxicillin as Bulk Drug and in Drug Formulation by Derivatization, International Journal of PharmTech Research, 2018, 11(2), 108-118.
14. Dhoka M.V., Gawande V.T., Joshi P.P, HPTLC Determination of Amoxicillin Trihydrate and Bromhexine Hydrochloride in Oral Solid Dosage Forms, Journal of pharmaceutical science and research, 2010, 2(8), 477-483.
15. ICH Q2 (R1): for validation of analytical procedures: text and methodology, 2005
16. Indian Pharmacopoeia 2010, Government of India Ministry of Health and Family welfare, Ghaziabad, New Delhi, Volume II: 813.
17. Md. Sahab Uddin, Abdullah Al Mamun, Mamunur Rashid and Md. Asaduzzaman, In-Process and Finished Products Quality Control Tests for Pharmaceutical Capsules According to Pharmacopoeias, British Journal of Pharmaceutical Research, 2016, 9(2): 1-9.
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