Sachin Khopade’s research while affiliated with Maharashtra Industrial Development Corporation and other places

Comparative analysis of the quality control tests for in-process and finished oral solid dosage form specifically tablets and capsules across the recent editions of the Indian Pharmacopoeia (IP), British Pharmacopoeia (BP) United States Pharmacopoeia (USP). This study provides a detailed examination of the in-process quality control (IPQC) tests as per the recent editions of Indian Pharmacopoeia (IP) 2022 (Addendum 2024), British Pharmacopoeia (BP) 2025, and United States Pharmacopoeia (USP) 2024 (Issue 3) for oral solid dosage forms, primarily tablets and capsules. It highlights the quality control measures implemented to ensure that the final products confirm to established pharmacopoeial standards. The concept of total quality control involves a comprehensive approach to producing a high-quality product by implementing various measures to eliminate errors at every stage of production. In-process testing is conducted to ensure that the final product meets the compendial standards outlined in pharmacopoeias. Since the final sample used for testing is only a representative sample from a larger batch, there may still be variability. Pharmacopoeias define specific limits within which values must fall to comply with the established standards. These official pharmacopoeias, recognized globally, outline the quality requirements for pharmaceutical products. The purpose of this review is to list the quality control tests, their differences, and similarities in relation to the pharmacopoeias stated above. The review covers various IPQC tests, including those related to physical, chemical, and microbiological attributes, and discusses the specific limits and criteria set by each pharmacopoeia. The study underscores both the similarities and differences in quality requirements among these pharmacopoeias. The review shows that IP, BP, and USP have similar quality control tests, but they each have their own specific requirements and methods for these tests. This divergence reflects the individual pharmacopoeias’ unique approaches to ensuring product quality. Understanding these differences is crucial for pharmaceutical manufacturers to ensure compliance with relevant pharmacopoeial standards and to maintain the quality and safety of oral solid dosage forms across different markets.

The stability-indicating method for Deflazacort Suspension was developed using the Analytical Quality by Design (AQbD) approach, focusing on process control and understanding. A multilevel factorial design was used to optimize the gradient mode's time and mobile phase ratio. Sophisticated software like Design Expert and Minitab aided in chromatographic condition optimization. The method utilizes a Zorbax Eclipse XDB C18 column (150mm x 4.6mm, 5µm particle size), with a flow rate of 1.0 mL/min, and monitoring the analyte with a UV/PDA detector at of 245nm wavelength known for its reliability. It employs two mobile phases: A, consisting of Water, Tetrahydrofuran, and Acetonitrile (91:3:6, v/v/v), and B, comprising Water, Tetrahydrofuran, Acetonitrile, and Methanol (4:2:74:20, v/v/v/v). Statistical analysis confirms the importance of these components in achieving effective separation and detecting related substances. The validation of method was done as per ICH guidelines. Linearity, specificity, Limit of Detection (LOD), Limit of Quantification (LOQ), precision, accuracy, solution stability, and robustness parameters were validated. The method was validated to ensure reliability and accuracy, demonstrating linearity from 0.02 to 1.2ppm with a correlation coefficient (r2 > 0.99) at 245nm. This confirms the method's ability to precisely quantify related substances in Deflazacort Suspension. The stability of Deflazacort Oral Suspension was rigorously assessed, including a forced degradation study. Critical system suitability parameters, tailing factor, and theoretical plate, met acceptable limits, confirming the method's efficiency and resolution. Successful separation of degradation peaks from each other and the main peak was achieved during the study. The method's robustness was confirmed with variations under 2%, ensuring consistent and reproducible results despite minor changes in conditions. Peak purity analysis showed no co-eluting peaks, confirming the method's specificity. These findings validate the stability-indicating nature of the chromatographic method for Deflazacort Oral Suspension analysis, ensuring its reliability for quality control.