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Abikesh Prasada Kumar Mahapatra1*, Basudev paul1, Amit Gupta2, Sucharitra Rani Sahu3, Vankayala Radhakrishna4, Suryanarayan Malla5
1OPJS University, School of Pharmacy, Churu, Rajasthan-331303, India
2School of Pharmacy, Devi Ahilya Vishwavidyalaya, Takshshila Campus, Indore (M.P.), India
3School of Pharmaceutical Sciences, Siksha O Anusandhan University, Bhubaneswar, India
4Research and Development, Dr Reddy's Laboratories Ltd, Telangana, India
5Alkem Laboratories limited, Taloja MIDC,Navi Mumbai-410208, India
*Address for Corresponding Author
Abikesh Prasada Kumar Mahapatra
OPJS University, School of Pharmacy, Churu, Rajasthan-331303, India
Abstract
Objective: The present study describes a simple, sensitive, fast, accurate, and cost-effective UV (Ultraviolet) spectrophotometric method for the determination of moclobemide in its various pharmaceutical dosage forms. Materials and methods: This UV spectrophotometric method is used the first time and has been applied for the quantification and determination of moclobemide drug substances in pharmaceutical formulations with suitable validation parameters and stability studies. Results: A stable, precise, and stability-indicating ultraviolet spectrophotometric method was developed for the analysis of the moclobemide in the presence of the degradation products. It involves method development by validation and force degradation studies; in which distilled water, hydrochloric acid as acidic environment, sodium hydroxide as basic treatment, hydrogen peroxide as oxidation agent were used as solvents. Two methods (method A and method B) were developed. Method A involves for method development and validation studies whereas method B involves forced degradation studies. Beer’s law was followed and showed peak maxima at 239 nm wavelength. The method was validated for linearity, accuracy, precision, sensitivity, specificity, recovery, robustness, and ruggedness as per the ICH guideline. The results of the forced degradation study also indicated that the developed ultraviolet method is capable of detecting percent degradation in different stress conditions, which signifies that the developed method is robust and stable. Conclusions: Statistical analysis of the data showed that the proposed UV spectrophotometric method is novel, reproducible, accurate, and precise while being simple and rapid for the determination of moclobemide in bulk drugs and its pharmaceutical formulations.
Keywords: Moclobemide, UV spectrophotometric method, method development, force degradation studies, validation
