1Department of Quality Assurance, Dayanand College of Pharmacy, Latur, Maharashtra.
2Department of Pharmaceutics, Dr L H Hiranandani College of Pharmacy, Ulhasnagar, Maharashtra.
3School of Pharmacy, Swami Ramanand Teerth Marathwada University, Nanded, Maharashtra.
4GVM College of Pharmacy, Murthal Road, Sonipat, Haryana, India.
5Central Ayurveda Research Institute, Jhansi, Uttar Pradesh; 284002, Ministry of Ayush, Government of India.
6Department of Pharmaceutical sciences, Vishveshwarya Group of Institutions, Gautam Buddh Nagar, Uttar Pradesh, India.
Analytical technique’s is a wide-ranging concept covering all matters that individually or collectively influence the quality of the product. Highly specific and sensitive analytical techniques hold the key role to the design, development, standard and quality control of medicinal products. Quality of drug products is very vital, as it involves life. Proper manufacture and quality control of pharmaceuticals is the vital segment of strong primary healthcare program worldwide. Pharmaceutical analysis, a branch of pharmacy, plays a very significant role in quality control of pharmaceuticals through a rigid check on raw materials used in manufacturing of formulation and on finished products. Few analytical methods such as spectroscopic method and chromatographic methods are used for quality control and validation of drugs. In this research article we used RP-HPLC method for development and validation on Olaparib tablets. Olaparib is primarily used for the treatment of ovarian and breast cancer. The purpose of this research is to develop method of a drug and which can be optimized according to different parameter and to validate according to ICH (Q2 R1) guidelines. All the research work was carried out in a systematic, concise, and serial manner which includes a thorough study by literature available for the analysis of Olaparib drug. In this research article we have done optimization of Olaparib tablets using RP-HPLC method with the help of 4 trials for optimization and in validation we have studied about these parameters specificity, linearity, range accuracy, precision, system suitability and robustness.
Gopal Lohiya, Saurabh Rahatkar, Rohini Ghotmukale, Swapnali Delmade, Kranti Satpute, Sanket Dharashivkar, Surendra G. Gattani, Sunny Chauhan, Sudhanshu Kumar Jha*, Divyam Maheshwari, RP HPLC Method Development and Validation on OLAPARIB Tablets, Int. J. in Pharm. Sci., 2023, Vol 1, Issue 9, 227-240. https://doi.org/10.5281/zenodo.8332607