Ratnakar Tripathi,
Bhushan Korde,
Sunil Kumar Shah,
B.K Dubey,
Deepak Kumar Basedia,
- Research Scholar, Department of Pharmaceutical Chemistry, Technocrats Institute of Technology-Pharmacy, Bhopal, Madhya Pradesh, India
- Research Scholar, Department of Pharmaceutical Chemistry, Technocrats Institute of Technology-Pharmacy, Bhopal, Madhya Pradesh, India
- Research Scholar, Department of Pharmaceutical Chemistry, Technocrats Institute of Technology-Pharmacy, Bhopal, Madhya Pradesh, India
- Associate Professor, Department of Pharmaceutical Chemistry, Technocrats Institute of Technology-Pharmacy, Bhopal, Madhya Pradesh, India
- Associate Professor, Department of Pharmaceutical Chemistry, Technocrats Institute of Technology-Pharmacy, Bhopal, Madhya Pradesh, India
Abstract
A sensitive, stability-revealing, and easy reverse-phase high-performance liquid chromatographic (RP-HPLC) technique was developed and rationalized to be in a position to determine Lercanidipine hydrochloride in ingested dosing preparations. It was separated by chromatography on a C 18 column using a mobile phase containing 10 mM potassium dihydrogen phosphate buffer and methanol (20:80, v/v; pH 4.0) at a flow rate of 1.0 mL/min and UV detected at 258 nm. The retention time of elution was 4.02 min using Lercanidipine hydrochloride. According to the requirements of ICH Q2(R1), specificity, linearity, accuracy, precision, robustness, sensitivity, and suitability of the system, the approach was proven to be consistent with ICH Q2(R1) requirements. The linearity of the technique was demonstrated to be large within the concentration range of 5-25 µg/mL with the correlation coefficient R2 0.9996. Precision and accuracy studies indicated a low value of the percentage recoveries as shown by accuracy study which reached out to 100 percent and a low percentage recovery as shown by a low preciseness study also attested to the reliability of the methodology employed. The limit of detection and limit of quantification were good enough and indicated that the method has been sensitive enough. Forced degradation study under acidic, alkaline, oxidative, thermal and implausible conditions suggested that the process could isolate the drug and its degradation products were exhibiting the fastest degradation rates (17.3%). The confirmed process was used on assaying a commercialized tablet preparation, which is successful and 98.50% of labelled claim was attained. Generally, the devised RP-HPLC method is robust, exact, and sensitivity-indicating that it can be applicable in the daily quality control process and the stability test of Lercanidipine hydrochloride in pharmaceutical dosage forms.
Keywords: Lercanidipine Hydrochloride; RP-HPLC; Stability-indicating method; ICH Q2(R1); Forced degradation; Pharmaceutical analysis.
Ratnakar Tripathi, Bhushan Korde, Sunil Kumar Shah, B.K Dubey, Deepak Kumar Basedia. Stability-Indicating Rp-Hplc Development and Validation for the Estimation of Lercanidipine Hydrochloride Content in Tablet Dosage Form. Research & Reviews: A Journal of Drug Formulation, Development and Production. 2026; 13(01):-.
Ratnakar Tripathi, Bhushan Korde, Sunil Kumar Shah, B.K Dubey, Deepak Kumar Basedia. Stability-Indicating Rp-Hplc Development and Validation for the Estimation of Lercanidipine Hydrochloride Content in Tablet Dosage Form. Research & Reviews: A Journal of Drug Formulation, Development and Production. 2026; 13(01):-. Available from: https://journals.stmjournals.com/rrjodfdp/article=2026/view=236092
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| Volume | 13 |
| 01 | |
| Received | 05/01/2026 |
| Accepted | 15/01/2026 |
| Published | 17/01/2026 |
| Publication Time | 12 Days |
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