Abstract:
Objective: Stability Indicating Analytical method Devlopment and Validation
for Simultaneous Estimation of Paracetamol and Zaltoprofen in Solid Dosage
Form.
Experimental work done: UV spectrophotometric estimation was carried out by First
order derivative method. Methanol was used as a solvent for UV spectrophotometric
method. HPLC method was performed by using C18, 5μ, 250 mm x 4.6 mm. Various
trials were performed for optimization of mobile phase. All these methods were
validated as per ICH guidelines.Various Stability parameters were also checked for
the degradation of drugs.
Results and Discussion: The selected optimized wavelength for spectrophotometric
methods, in First order derivative method were 268 nm and 248 nm, for estimation of
ZALTO, and PCM respectively. The optimized mobile phase for HPLC method
phosphate buffer : Acetonitrile pH 3.0 with OPA in the ratio of 65: 35 v/v gave peak
of ZALTO and PCM at Retention Time of 4.83 min. and 2.79 min. at λmax=260 nm.
% RSD for precision, accuracy and robustness for all methods was less than 2. In
Stability study HCl, NaOH, H2O2 were used in acid, Base and Oxidation and Thermal
Degradation respectively. Conclusion: The spectrophotometric and chromatographic methods developed are
sensitive, precise, accurate and reproducible for analysis of pharmaceutical
formulation. Results of method suggest that all the methods are repeatable and
specific for the estimation of ZALTO and PCM. Stability study suggest that no any
interference observed from any degradant peaks at retention time of ZALTO and
PCM.
