Method Development & Validation of Stability Indicating Assay Method of Clindamycin in Adapalene and Clindamycin Gel Formulation by RP-HPLC

  • K. Ranjith
  • Veera Shakar Pulusu
  • Raj K. Keservani
  • Ramanlal N Kachave
  • Durga Panikumar Anumolu
  • Navneet Tiwari
  • Himanshu Lohani
  • Anand Mundada
Keywords: Validation, Clindamycin Phosphate, Adapalene Stability Study

Abstract

Background: It is applied to the skin to treat bacterial vaginosis, which usually stops Propionibacterium acnes and acne vulgaris from growing on the skin.

Objectives: It was the goal of this study to create and test a new RP-HPLC method that can show stability while measuring stabilizers, CP, and ADA in topical gel formulations at the same time.

Material and Methods: The best way to separate analytes and stress-induced degradant peaks on the XBridge C18 (50 x 4.6 mm, 3.5 µm) column was to use a mobile phase that was a variable mix of acetonitrile, tetrahydrofuran, and ammonium hydrogen phosphate buffer (pH 2.50), along with gradient elution. At 210 nm, phenoloxyethanol, methylparaben, and clindamycin phosphate were found. At 321 nm, adapalene was found.

Results and Conclusion: The developed RP-HPLC method was validated for determination of Clindamycin using linearity, accuracy, precision, precision Day-2, Ruggedness, robustness, Specificity, Solution Stability Study. All parameters % RSDs were below two, demonstrating the method's validity and stability, and indicating that the assay results obtained using this procedure are highly consistent.

Author Biographies

K. Ranjith

General Manager-Quality Assurance, Sionc Pharmaceuticals Pvt. Ltd, JN Pharmacity, Parawada, Anakapalli, Andhra Pradesh, 531021, India

Veera Shakar Pulusu

Ohio University, Department of Chemistry & Biochemistry, Athens, OH, 45701, USA

Raj K. Keservani

Faculty of B. Pharmacy, CSM Group of Institutions, Prayagraj, Uttar Pradesh, 212111, India

Ramanlal N Kachave

GES’s Sir Dr. M. S. Gosavi College of Pharmaceutical Education and Research Nashik, Affiliated Savitribai Phule Pune University, Pune, Nashik, Maharashtra, 422005, India

Durga Panikumar Anumolu

Associate Professor, Department of Pharmaceutical Analysis, Gokaraju Rangaraju College of Pharmacy, Osmania University, Hyderabad, Telangana, 500090, India

Navneet Tiwari

Assistant Professor, Graphic Era Hill University Bhimtal, Nainital, Uttarakhand, 263136

Himanshu Lohani

Associate Professor, Samrat Prithviraj Chauhan College of Pharmacy Kashipur, Udham Singh Nagar, Uttarakhand, 244713, India

Anand Mundada

Associate Professor, R. C. Patel Institute of Pharmaceutical Education and Research, Shirpur, Dhule, Maharashtra, 425405, India

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Published
2024-10-04
How to Cite
K. Ranjith, Veera Shakar Pulusu, Raj K. Keservani, Ramanlal N Kachave, Durga Panikumar Anumolu, Navneet Tiwari, Himanshu Lohani, & Anand Mundada. (2024). Method Development & Validation of Stability Indicating Assay Method of Clindamycin in Adapalene and Clindamycin Gel Formulation by RP-HPLC. Revista Electronica De Veterinaria, 25(1S), 1247 - 1259. https://doi.org/10.69980/redvet.v25i1S.1100