ZERO ORDER AND AREA UNDER CURVE SPECTROPHOTOMETRIC METHODS FOR DETERMINATION OF AMOXICILLIN TRIHYDRATE IN PHARMACEUTICAL FORMULATION.
Objective: - A simple, accurate, precise and specific zero order and area under curve spectrophotometric methods has been developed for determination of Amoxicillin Trihydrate in its tablet dosage form by using methanol as a solvent.
Â Methods: - (1) Derivative Spectrophotometric Methods: - The amplitudes in the zero order derivative of the resultant spectra at 229 nm was selected to find out Amoxicillin Trihydrate in its tablet dosage form by using methanol as a solvent.
(2) Area under curve (Area calculation): -The proposed area under curve method involves measurement of area at selected wavelength ranges. Two wavelength ranges were selected 224-232 nm for estimation of Amoxicillin Trihydrate.
Result & Discussion: -The linearity was found to be 5-25 Î¼g/ml for Amoxicillin Trihydrate. The mean % recoveries were found to be 100.33% and 99.42% of zero order derivative and area under curve method of Amoxicillin Trihydrate. For Repeatability, Intraday precision, Interday precision, % RSD were found to be 0.0036, 0.0028 and 0.5987, 0.4188 for zero order and 0.0019, 0.0031 and 1.6357, 1.7159 for area under curve method respectively. Limit of Detection and Limit of Quantitation were found to be 0.9142Î¼g/ml and 2.8128Î¼g/ml for zero order and 0.5798Î¼g/ml and 1.3153Î¼g/ml for area under curve method respectively. Assay results of market formulation were found to be 100.84% for zero order and 99.65% area under curve method respectively. The proposed method has been validated as per ICH guidelines and successfully applied to the estimation of Amoxicillin Trihydrate in its Tablet dosage form.
Conclusion: - The developed methods can be concluded as accurate, sensitive and precise and can be easily applied to the pharmaceutical formulation.
Madhura Dhoka, Shakuntala Sandage , Snehal Dumbre. Analytical Method Validation and Statistical Evaluation of Spectrophotometric Methods for Simultaneous Estimation of Amoxycillin Trihydrate and Ambroxol Hydrochloride. Asian Journal of Biochemical and Pharmaceutical Research. 2011; 2 (1): 585-592.
Sharma R, Pathodiya G, Mishra GP, Sainy J. A novel spectrophotometric methods for quantitative determination of ciprofloxacin hydrochloride and tinidazole in tablets using hydrotropic solubilizing agent. Journal of Pharmacy Research.2011; 4 (3): 859-861.
Sonawane LV, Kumar S. Development and validation of RP-HPLC method for the simultaneous estimation of amoxicillin trihydrate and bromhexine hydrochloride from oily suspension. Pharmaceutica Analytica Acta.2010; 1(2): 1-6.
Khan HA. Stability indicating HPLC method for simultaneous estimation of metronidazole and amoxycillin trihydrate. Online thesis at RGUHS University. 2010.
Chakravarthy KK, Darak V, Arshad MD and Bharath SA. Development and validation of simultaneous spectrophotometric estimation of doxycycline and tinidazole in tablet dosage forms. International Journal of Pharmacy and Pharmaceutical Science. 2010; 2(2): 534-539.
Marianne Alphonse Mahrouse, Development and Validation of A UV Spectrophotometric Method for TheSimultaneous Determination of Ciprofloxacin Hydrochloride and Metronidazole in Binary Mixture. Journal of Chemical and Pharmaceutical Research. 2012; 4(11): 4710-4715
Durga Mallikarjuna Rao Tippa, N. Singh, Development and Validation of Stability Indicating HPLC Method for Simultaneous Estimation of Amoxicillin and Clavulanic Acid in Injection. American Journal of Analytical Chemistry.2010; 1(3): 95-101.
Dhoka M, Gawande V, Josh P. High-performance liquid chromatographic method for determination of amoxicillin trihydrate and bromhexine hydrochloride in oral dosage form. International Journal of Pharmacy and Pharmaceutical Science. 2010; 2(1): 129-33.
M. J. Lebella, W. L. Wilson and G. Lawriault. High Performance Liquid Chromatographic Determination of Amoxicillin in Pharmaceutical Dosage Forms. Journal of Chromatography. 1980; 202(1): 144-147.
Dhiraj S. Nikam, Chandrakant G. Bonde, S.J. Surana, G. Venkateshwarlu, P.G. Dekate. Development and Validation of Rp-Hplc Method for Simultaneous Estimation of Amoxicillin Trihydrate and Flucloxacillin Sodium in Capsule Dosage Form. International Journal of Pharmtech Research. 2009; 1(3): 935-939.
International Conference on Harmonization (ICH) of Technical Requirements for the registration of Pharmaceuticals for Human use, Validation of Analytical Procedures Methodology; ICH-Q2(R1), Geneva. 1996; 1-8.
Parasvirani, Rajanitsojitra, Hasumatiraj, Vineet Jain. Development and Validation of Analytical Method for Irbesartan and Atorvastatin by Simultaneous Eqution Spectroscopic Method. Innovare Journal of Sciences. 2015; 3(1): 11-15.
Parasvirani, Rajanit Sojitra, Bhadresh Savaj, Hasumatiraj, Vineet Jain. Simultaneous Estimation of Irbesartan and Atorvastatin by First Order Derivative Spectroscopic Method in Their Synthetic Mixture Use in Hypertension Condition. Innovare Journal of Sciences. 2015; 3(1): 16-20.