ABSTRACT:
Background: An Aceclofenac and Cyclobenzaprine HCl is NSAID and antidipressive agent, a rare combination. Objective: The aim was to develop and validate new UV-spectrophotometric methods. Method: In first method (M-I) simultaneous estimation with forced degradation was performed. In second method (M-II) simultaneous estimation by derivatization technique was performed. In third method (M III) the simple simultaneous estimation was performed. The abbreviations ACE and CYC are used for Aceclofenac and Cyclobenzaprine HCl in the current manuscript. Results: In method I, the linearity range was obtained as 5 - 25µg/ml with correlation coefficient 1 respectively. The results were 99.45% 99.50% 99.97% 99.78% 99.36% 99.67% respectively for both the drugs. The forced degradation for both drugs by applying the method was carried out. In method II, the derivatization with 2% ninhydrin was carried out. The correlation coefficient was obtained as 1 for both the drugs respectively. The recovery study values were obtained as 95.60%, 95.95%, and 95.53% 95.85% 98.82% 98.33% respectively for both the drugs. In the method III, the correlation coefficient of both the drugs was 1. The recovery study values were obtained as 99.56-100.32% 99.05 – 100.2% for both drugs respectively. Conclusion: All values were obtained in the acceptable range of as per ICH guidelines. The forced degradation was useful to obtain stability indicating data for this combination. The derivatization technique is first time used for the analysis of this combination. The one-way analysis of variance (ANNOVA) shows no significant difference among these three methods. As no methods are available for this new and recent combination, these methods can be routinely used for the analysis of these drugs.