Research Articles

2017  |  Vol: 2(6)  |  Issue: 6 (November-December)

Implementation of statistical tools and novel approaches to develop and validate the method for the estimation of pazopanib in bulk, tablets and fabricated Nano-sized formulation

Sameer J. Nadaf^1,2, Suresh G. Killedar^1*

¹Bharati Vidyapeeth College of Pharmacy, Near Chitranagari, Kolhapur-416013, Maharashtra, India.

²Adarsh College of Pharmacy, Bhavaninagar, Vita-415311, Maharashtra, India.

*Address for correspondence

Dr. Suresh G. Killedar

Bharati Vidyapeeth College of Pharmacy, Near Chitranagari, Kolhapur-416013, Maharashtra, India.

Phone: +91-231-2637286

Abstract

Background: Spectrophotometry states the material properties (reflection or transmission) as function of wavelength. Objectives: Aim of current work is to develop a simple, rapid, and cost effective spectrophotometric method for the determination of pazopanib in fabricated nano-formulation and marketed formulation. Materials and methods: Methanol was optimized as solvent for pazopanib and further spectrophotometric detection was carried at analytical wavelength i.e. 214 nm. The method was further validated as per International conference on Harmonisation (ICH) guidelines for linearity, specificity, accuracy, precision, ruggedness and robustness. Results: The concentration of pazopanib over range of 1-08 µg/ml obeys Beers law (R²= 0.9996). Percent Recovery estimated was found to be 99.29 ± 0.23. The limit of detection (LOD) and limit of quantification (LOQ) was found to be 0.139 μg/ml and 0.464 μg/ml respectively. Statistical analysis showed high accuracy and good precision of proposed method. Shapiro-Wilk test (P=0.5473) and Kolmogorov-Smirnov test (D=0.1212; P>0.10) accepted the normality of data. Bland-Altman plot demonstrated a satisfactory repeatability coefficient. Youden Plot demonstrated the exceptional inter-laboratory reproducibility and it was used to identify random and total errors. Control charts like Levey-Jennings chart, X- chart showed that method is under statistical control. CUSUM chart revealed about targetability of the method. Capability analysis demonstrated greater values of Cp (1.93) and Cpk (1.75) than 1, indicating the capability of method to analyze the samples accurately and consistently with minimum variation. Conclusion: Validation report assured that common excipients from commercial formulations don’t interfere with the proposed method, hence can be applied in regular laboratory analysis.

Keywords: Pazopanib, Accuracy, Precision, UV-method development, Validation