DEVELOPMENT AND VALIDATION OF UV VISIBLE SPECTROPHOTOMETRIC METHOD FOR ESTIMATION OF ACECLOFENAC AND TRAMADOL IN BULK AND DOSAGE FORMAbstract
Objective: Simple, rapid, sensitive, precise and reproducible specific UV spectrophotometric method for the determination of Aceclofenac (ACE) and Tramadol (TRM) in bulk drug and pharmaceutical dosage form were developed and validated. Methods: A simple double beam UV spectrophotometric method has been developed and validated with different parameters such as linearity, precision, repeatability, limit of detection (LOD), Limit of Quantification (LOQ), accuracy as per ICH guidelines. Results: UV-visible spectrophotometric method, measurement of absorption at maximum wavelength in 10 ml methanol and volume make with water solvent system as reference ACE and TRM were found to be at 203 nm and 241 nm respectively. The drug obeyed the Beer’s law and showed good correlation. Beer’s law was obeyed in concentration range 5 – 25 µg/ml for ACE and 2 – 10 µg/ml for TRM respectively with correlation coefficient was 0.999. The LOD and LOQ of ACE were found to be 4.7862 μg/ml and 14.50 μg/ml, TRM were found to be 2.0518 μg/ml and 6.2176 μg/ml, respectively. Percentage assay of ACE and TRM in tablets. Conclusion: The proposed method is simple, precise, accurate and reproducible can be used for routine analysis of ACE and TRM in bulk and tablet dosage form.
S. Mali *, S. Ahmad and V. M. Shastry
Department of Quality Assurance, Gangamai College of Pharmacy, Nagaon, Dhule, Maharashtra, India.
08 December, 2017
16 February, 2018
19 February, 2018
01 September, 2018